CANCER CARE OUTCOMES RESEARCH AND SURVEILLANCE CONSORTIUM Release Date: August 24, 2000 RFA: CA-01-013 - (Reissued as RFA-CA-09-503) National Cancer Institute Letter of Intent Receipt Date: October 15, 2000 Application Receipt Date: January 24, 2001 PURPOSE The Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to support a new collaborative research consortium that would conduct Cancer Care Outcomes Research and Surveillance (CanCORS). Research institutions are invited to apply for primary data collection and research site (PDCR) awards that would support the conduct of prospective studies in newly diagnosed cohorts of lung and colorectal cancer patients. These prospective studies will collect information about medical care practices used to manage patients over the course of their disease, various outcomes associated with these practices, and information about patient and provider behaviors and perceptions. This information will be collected in order to address three goals reflecting major NCI research priorities: 1) Enhance monitoring and understanding of the processes of cancer care and the patient-centered factors influencing prognosis in population-based cohorts of patients. 2) Establish a system for examining the relationship between the processes of care and clinical and patient-centered outcomes, with emphasis on measuring the dissemination of state-of-the-science interventions and their association with better quality outcomes in the general population of cancer patients. 3) Examine disparities in the receipt of state-of-the-science cancer care and factors that contribute to disparities in outcomes, such as health-related quality of life (QOL), and identify ways to lessen those disparities. This RFA is the first major step by NCI to support the development of a system for obtaining details about cancer care beyond the initial diagnosis and limited treatment data that are now routinely collected in high quality population-based cancer registries. This research will help build the information base needed for measuring and improving the quality of cancer care in the US. This RFA cooperative agreement will fund individual grantees who will be formed into the CanCORS Consortium whose purpose will be to collaboratively collect and analyze process-outcome relationships in patients newly diagnosed with lung or colorectal cancer. Applicants must propose specific research hypotheses to serve as the scientific foundation of this data collection system. In addition, separate applications are invited to support a CanCORS Statistical Coordinating Center (SCC). The primary objectives of the SCC will be to develop and support the collection of standardized, core data across individual research sites, and to serve as the central repository for the analysis of pooled data. NCI has established a CanCORS website which includes answers to frequently asked questions to further assist potential applicants: http://www-dccps.ims.nci.nih.gov/ARP/cancors.html. RESEARCH OBJECTIVES Background The overall goal of the national cancer research program is to reduce mortality and morbidity from cancer in the US population. Current surveillance systems, including the Surveillance, Epidemiology, and End Results (SEER) Program established in 1973, track incidence, survival, and mortality rates in parts of the population. Specific measures of the burden of cancer in terms of process and outcomes of care were identified in the Measures of Progress Against Cancer report to the U.S. Senate Appropriations Committee in 1990 (see ref #1). In that report, an expert panel recommended that the NCI systematically track patterns of care and assess services delivered to cancer patients. The NCI responded to this recommendation by conducting SEER-based, cross-sectional studies of practice patterns, establishing the SEER-Medicare data base, and sponsoring other special targeted surveys. External review groups and committees, most recently the Institute of Medicine’s (IOM) National Cancer Policy Board (NCPB) (see ref #2), the Cancer Surveillance Research Implementation Group (http://dccps.nci.nih.gov/DCCPS/SIG/), and NCI’s Progress Review Groups, including the Colorectal Cancer Progress Review Group (http://osp.nci.nih.gov/Prg_assess/PRG/CPRG/default.htm have all urged the NCI and other research agencies to expand cancer care surveillance research beyond these efforts, and to include the study of the process and outcomes of cancer care in national, longitudinal, population-based patient cohorts. One example of such studies is the Prostate Cancer Outcomes Study (PCOS) (http://www-dccps.ims.nci.nih.gov/ARP/PCOS/index.html). One of the NCPB’s specific recommendations was to support national studies of newly diagnosed cancer patients using data sufficiently detailed to assess patterns of care and their relationship to valued outcomes (Recommendation 8). A second was to investigate why specific segments of the population are not receiving quality cancer care, and to explore ways of removing access barriers (Recommendation 10). The earlier Cancer Surveillance Research Implementation Plan (prepared by the Surveillance Implementation Group, NCI, March 1999) also noted this suggestion, under priority area #1, suggesting the collection of data on patterns of care, health status, morbidity, and quality of life as well as cohort studies of newly diagnosed registered cancer patients for the purpose of documenting levels and trends in these parameters . This RFA is part of the NCI’s response to these recommendations, as embodied in the NCI Director’s remarks to the IOM on 5 October 1999. It is also consistent with the NCI Director’s two challenge areas regarding quality of care and health disparities, and is consistent with the mission of the DCCPS to monitor and report on diverse measures of the burden of cancer in the population. This expansion of research on cancer care delivery is complementary to the goals of the Department of Health and Human Services Quality Improvement Initiative and also to the trans-departmental Quality Interagency Coordination Task Force (QuIC). The vehicle for coordinating these efforts in cancer care is the NCI-chaired Quality of Cancer Care Committee, a transagency working group that includes representatives from other Federal agencies involved in the delivery, payment, or regulation of cancer care. The long-term goal of the research to be supported by this RFA is to provide a stronger, more representative empirical evidence base of process-outcome linkages in the delivery of care used to treat, monitor, and palliate cancer patients. The goal is not to promulgate guidelines or recommendations by a specific organization or institution, or to compare the patterns of care in the community setting against an external "standard" suggested by a specific guideline. However, the extent to which different guidelines are used and the effect of their use on patient outcomes is an example of an association that can be examined in response to this RFA. A central focus of NCI’s outcomes research program is on developing methods for defining, measuring, and reporting on the quality of cancer care. Currently, the NCI and other Federal and private research organizations support cross-sectional studies describing cancer practice patterns that rely primarily on cancer registries that are based on hospital records or linked data bases such as SEER-Medicare. The CanCORS initiative represents the next important and logical step in furthering the research agenda on quality of cancer care by identifying process and outcome measures that can eventually be incorporated into a national data system for monitoring and improving that care. Studies supported by this RFA will permit much more in-depth assessments of cancer care and its relationship to outcomes in diverse populations and delivery settings than any prior systematic research efforts in this field. Such large scale studies have yet to be supported because of their size and complexity. Over time, the knowledge gained from CanCORS will help to identify the core elements of a national, shared data system on quality of care that can be used by patients, providers, researchers, and health plans. Definitions AWARDEE: The institution to which the UO1 grant is awarded, including both PDCR sites and the SCC. NCI PROGRAM DIRECTOR: Scientist administrator from the NCI extramural staff, the Program Director will not only provide normal stewardship for the UO1 grants awarded under this RFA, but will also be involved in the scientific coordination and collaboration within the CanCORS Consortium and will coordinate and facilitate interaction among the awardees. PRINCIPAL INVESTIGATOR (PI): The investigator who is designated by the applicant organization to direct the project to be supported by the UO1 grant. The PI will assume the responsibility and accountability to the applicant organization officials and to the NCI for performance and proper conduct of the research supported by the UO1 mechanism. Each institution may have more than one CanCORS PI, and a single person may be the PI for applications that include both lung and colorectal cancer. NCI SCIENTIFIC STAFF: Scientific staff from NCI’s extramural and intramural programs called upon to provide their expertise to the CanCORS Consortium efforts. CanCORS CONSORTIUM: The newly formed entity created under this RFA by joining together individual awardees for the purpose of conducting collaborative research on process-outcome relationships in a longitudinal cohort of lung and colorectal cancer patients. PRIMARY DATA COLLECTION AND RESEARCH (PDCR) SITE: An awardee, consisting of an institution or organization which is responsible for primary data collection of core processes and outcomes of cancer care, reporting core data to the central SCC, and performing statistical analysis of pooled data. PDCR sites may have their own data collection infrastructure or may partner with other data collection entities. STATISTICAL COORDINATING CENTER (SCC): Single awardee responsible for data transfer from PDCR sites, storage, documentation, and formatting for pooled statistical analysis by investigators from PDCR sites or from the SCC. Will also support development of standardized data collection at participating PDCR sites and advancement of study design and statistical techniques for the Consortium as a whole. CORE DATA ELEMENTS: Variables pertaining to processes of care (or interventions to manage, treat, and palliate cancer patients) and outcomes of care (including traditional endpoints such as recurrence and mortality, as well as patient-oriented outcomes such as quality of life, satisfaction, and economic burden) to be collected by all participating PDCR sites for pooled analysis. SPECIAL RESEARCH PROJECTS: Smaller ancillary studies proposed by individual applicants that complement the collection and/or the analysis and interpretation of core data. Each PDCS applicant must propose at least one but no more than two such projects, and SCC applicants must propose at least one but no more than three special projects. CanCORS STEERING COMMITTEE (CSC): A committee consisting of the PI’s from each of the PDCR sites, the PI of the SCC, the NCI Program Director, and one person from the NCI scientific staff as designated by the NCI Program Director. A PDCR site may include an additional representative on the CSC if that site is participating in data collection for both lung and colorectal cancer. The Chair of the CSC will be one of the PI’s as selected by the CSC. The CSC can admit additional non-federal non-voting members as they deem necessary. The CSC will provide overall scientific direction for the CanCORS Consortium and establish and oversee policies and procedures. DATA STANDARDS COMMITTEE (DSC): Formed by the CSC, the DSC will be responsible for defining the core data elements selected by the CSC or its designees. The DSC will be responsible for assisting and coordinating the collection and reporting of standardized, quality data by all participating sites to the SCC. The DSC will be chaired by the PI of the SCC, and will include other members named by the CSC. Non-federal persons from outside the Consortium may be added to advise the DSC, if such expertise is not available from within the Consortium. PARTICIPATION MONITORING COMMITTEE (PMC): Formed by the CSC, the PMC will be responsible for monitoring the adherence of all research sites to the uniform study protocol established for collection of core data elements, and monitoring patient response rates, attrition, and cooperation of local providers with data collection activities. The PMC members from within the Consortium will be named by the CSC. Non-federal persons from outside the Consortium may be added to advise the PMC, if such expertise is not available from within the Consortium. CanCORS WORKING GROUP (CWG): Named by the CSC, this group will consist of persons from outside the CanCORS Consortium who will provide advice (of its individual members) to the CSC regarding overall strategies, study designs, analysis plans, and results. Scope The study of lung and colorectal cancer practice patterns and associated outcomes can be achieved by means of a coordinated, prospective study conducted by 5-12 PDCR sites with a central SCC for data coordination and reporting. The PDCR sites will enroll and collect core data on a total of approximately 6,000 newly diagnosed cases per cancer. Enrolling a large sample of patients for longitudinal studies will permit assessments of process-outcome relationships across diverse population sub-groups and health care delivery systems. Applicants may participate in the study of one or both cancers. Each PDCR site will be required to collect standardized, core variables pertaining to cancer-specific practices used to treat, monitor, and palliate cancer patients, and patient outcomes associated with these practices. Other core data elements will be likely confounding factors, such as comorbidity, socio-demographic, and economic variables. All core data will be reported to the central SCC for pooled analysis to be carried out collaboratively by all participating investigators. Final selection of core variables to be collected across participating research sites will be jointly determined by the CanCORS Steering Committee (CSC) during the first year of the project. In addition to information about cancer care and outcomes, applicants are invited to propose collection of other factors potentially associated with long-term prognosis, such as lifestyle factors. Such information may be proposed as part of the core study, or as a special research project to be conducted in selected sub-samples of enrolled patients. Given the disproportionately high cancer burden borne by some population subgroups, emphasis should be placed on assessing reasons for disparities in processes and outcomes of cancer across age, gender, socioeconomic and racial- ethnic groups. Research questions on this topic should focus not only on describing differences in care, but on investigating the underlying reasons for such variations related to patient characteristics such as age and comorbidity, patient preferences, provider characteristics, and health system organization and reimbursement attributes. The development of large, observational studies in community settings serves as an important adjunct to the NCI’s clinical research program. The types of studies to be carried out will complement what is learned from randomized clinical trials by assessing the dissemination and impact of new knowledge in the population. There exists a wide spectrum of evidence about the efficacy of cancer treatments, ranging from treatments known to be efficacious based on evidence from Phase III randomized clinical trials (RCT), to interventions for which there is no clear consensus about the efficacy of various treatment options. For such interventions, there are numerous other factors that may dictate patterns of practice. For the sake of more clearly describing the objectives of this RFA, these two categories are discussed separately below. A. Treatments with proven efficacy from RCTs The main focus of studies for such treatments will be to assess the dissemination of evidence-based care to the larger, general population. The assessment should include cross-sectional descriptions of variations in practice patterns in diverse care settings, and comparisons of cancer outcomes in RCTs with outcomes observed in non-protocol settings. Dissemination of RCT-proven interventions to the general population may be limited because providers may not quickly adopt new treatments on the one hand, or patients in community practices may not be directly comparable to participants in well- controlled RCTs. Thus, it is important to measure outcomes of RCT-proven therapies in population-based clinical settings. An improved understanding of the many factors that encourage or inhibit patient access to efficacious interventions is a necessary first step in the overall research agenda aimed at increasing the proportion of cancer patients in the US who receive high quality cancer care. Applicants will also be asked to address provider issues. For example, physician attitudes and knowledge, and health care delivery system factors might affect the dissemination of cancer treatments. Access to specialists versus generalists may also influence processes and outcomes that could be assessed across different types of health care delivery organizations. Applicants should consider the assessment of multiple factors that may be associated with poor dissemination of RCT-proven cancer-related practices among vulnerable populations defined by age, socioeconomic status, and some racial/ethnic groups who traditionally experience higher mortality from cancer. B. Treatments with unproven mortality benefits or therapeutic options not yet compared in RCTs As in the case of proven therapies for cancer based on RCTs, it is first necessary to characterize practice patterns where there is no clear consensus about best practices and the underlying reasons for variations across populations, including patient factors, preferences, and provider factors. The main purpose of measuring outcomes will differ in the case of unproven interventions, since there is no standard of care based on RCT evidence against which to compare community-based outcomes. Information to be obtained through linking process with outcomes in observational studies can serve at least two important purposes. First, the association between processes and outcomes of cancer care in situations of uncertain efficacy will enhance clinical decision making by giving both patients and clinicians an expanded evidence base upon which to choose among competing therapeutic strategies. Observational studies cannot definitively establish the superiority of one treatment versus another in terms of curative potential. However, information about other outcomes important to patients, such as side-effects and QOL, can be obtained in diverse patients and delivery settings to provide a more complete picture of possible outcomes from specific treatments. Additionally, observational studies in large, representative cohorts can help develop hypotheses to be tested in new clinical trials by raising questions about the cost-benefit tradeoffs of therapies that are currently delivered in everyday, real-world health care settings. Another research objective is to measure the prevalence of long-term functional limitations due to cancer or sequelae of treatments, as well as the effectiveness of palliative treatments for these sequelae or disease-specific functional limitations. Applicants should describe the potential significance of information as the foundation for new research directions focusing on the development of cost-effective behavioral and health services interventions designed to alleviate cancer morbidity in the population. However, intervention research per se will not be supported under this RFA. Research Objectives PDCR site applicants must specify research hypotheses relating to lung or colorectal cancer practices and associated outcomes. Specific hypotheses to be proposed by applicants should address the following five general research objectives of this RFA: 1. Cross-sectional analysis of practice patterns for cancer patients according to multiple patient clinical and sociodemographic characteristics; assessment of other determinants of access to cancer care services according to patient, health care delivery system, and physician characteristics; evaluation of awareness of cancer clinical trials and CancerNet. 2. Analysis of underlying reasons for variations in cancer practices and outcomes among vulnerable populations, defined by age, socioeconomic status and racial-ethnic identification. 3. Longitudinal assessments of outcomes, and how outcomes are mediated by variations in the processes and structure of care over the course of the disease, i.e., during initial, continuing, or terminal phases of cancer care. 4. Identification of patient, provider, and health system factors influencing the dissemination and effectiveness of interventions that have been demonstrated in randomized studies to reduce cancer-specific mortality or morbidity, or improve health-related QOL. 5. Assessments of the contribution of modifiable lifestyle factors on prognosis and health outcomes. Such information may be collected on specific sub-samples for whom such information is most relevant. PDCR site applicants are encouraged to incorporate methodological studies to identify, develop, and validate process and outcome measures most useful for clinical decision making, as well as to develop more efficient, standardized, automated data collection methods on processes and outcomes of cancer care. Applicants are encouraged to consider novel ways of prospectively collecting information on processes of care, for example, through the use of emerging clinical informatics systems. PDCR site applicants are invited to suggest sampling designs that permit oversampling of specific sub-groups defined by sociodemographic or clinical criteria to address high priority areas of interest. In order to track temporal trends in care, or to track newly emerging technologies that arise during the award period, applicants may propose the identification of new, additional incident cohorts of lung or colorectal cancer patients to be added during the term of the award and supported through administrative supplements. Core Data Elements For the purpose of assessing cancer care delivery in the general community setting, awardees must reach agreement on the core measures and variables to be collected across all primary data collection sites. PDCR site applicants must propose candidate core data elements based on specified research hypotheses. This serves as the beginning of the process of selecting final core measures. The final selection of core variables will be made during the first year of the project by the CSC (see more on the structure and function of the CSC under Terms and Conditions). Specific instruments or questionnaires to measure core elements will be selected by the CSC, or through other procedures established by the CSC. For example, a designated sub-committee may be charged with responsibility for instrument selection or development of original instruments as required. The NCI’s CanCORS webpage (http://www-dccps.ims.nci.nih.gov/ARP/cancors.html) includes an outline of general core process and outcome measures that serves as a reference point for prospective applicants to encourage some commonality among the individual applicants. However, applicants are not restricted to these core issues or questions. The website also contains a separate link describing examples of disease-specific questions relating to processes of care for lung and colorectal cancer that span the continuum of care spanning from diagnosis through terminal care. These suggested measures serve as the foundation for core data elements to be collected by all Consortium research sites. After awards are made applicants must be willing to work with other Consortium sites to select and define these core measures. Applicants should review these outlines in preparation of their applications. Study Protocol A crucial element of the collection of core data in the CanCORS Consortium will be the study protocol specifying the precise methods and timing for collecting core data uniformly. Although applicants are required to propose a protocol for data collection specific to to their own site in applications, the common protocol to be used by all research sites will be finalized by the CSC or its designees during the initial year of the project. For the purpose of helping applicants estimate the resources necessary to collect core data, it is anticipated that there will be 2 waves of a mixed mode (self- administered mail initially) patient survey, performed at baseline (approximately 4-6 months post-diagnosis) and repeated approximately 1-2 years later. Provisions and procedures for interviewing surrogates or next-of-kin for deceased patients should be described in applications. A modest payment for the study participants, such as $20-50, may be included to enhance participation and compensate participants for their time. Research applications will also require a baseline medical record review, involving abstraction of all sources of cancer-related providers of care within the first 1-2 years of diagnosis, and a re-abstraction of a sample of cases (such as 20-40%) 1-2 years after the baseline medical record reviews. Additional contacts to enhance accrual and retention, such as informational or promotional materials, with patients or providers, should also be described in applications. Composition of PDCR Sites This RFA invites applications from research organizations, including those within academic institutions, cancer centers, state agencies, professional or managed care organizations. Participants in the Consortium may also include member institutions of Cooperative Groups or Community Clinical Oncology Program (CCOPs), large health care delivery organizations or professional societies, providing such organizations can demonstrate inclusion of a heterogeneous population of cancer patients with respect to socio-demographic characteristics and diverse health care systems with respect to organization and reimbursement characteristics. Organizations that lack access to such population-based patient or health care system samples may propose the development of innovative data collection systems for ensuring the necessary surveillance coverage of populations and health care practices appropriate to the research supported by this RFA. Coverage may also be accomplished through partnerships with data collection entities, such as population-based cancer registries, or other organizations with the capability of developing innovative health care data collection systems. Ideally, the composition of each PDCR site will be interdisciplinary, with expertise in clinical sciences, psychosocial and behavioral research, epidemiology, health services research, and biostatistics, at a minimum. Establishing local collaborations with relevant patient and provider partners, such as representatives from major professional societies, may be helpful in facilitating access to primary data sources essential for measuring community practice patterns and outcomes. Participation of patient advocacy groups is also strongly encouraged. Applications for PDCR sites will be strengthened by the participation of individuals with clinical expertise in the organ system under study, and individuals with statistical expertise in the analysis of observational data on health care services and outcomes. PDCR site applications must include documentation of prior experience in the collection of data regarding studies of cancer practice patterns and long term cancer outcomes. Such experience may include identification of incident patient populations within defined areas, abstraction of baseline clinical data from medical records, active follow up for vital status, patient surveys, and close ties with local providers. Experience with previous epidemiologic or health services research studies that involve similar activities to those required by this RFA should be documented as part of the demonstration of capability Approximate Timetable During year 1, each participating research site and the SCC will work collaboratively to select core data elements, finalize the study protocol for collection of core elements, obtain IRB approvals, and develop and test data collection and reporting procedures. Contacts with local provider groups and patient advocates will be made to facilitate cooperation of cancer patients with the research effort. Enrollment and initial data collection efforts will occur in years 2-3, including initial patient surveys and obtaining patient consent for review of medical records. Medical record abstraction to obtain records-based core variables will occur during years 3-4. Depending on the research hypotheses to be addressed as part of the core studies, additional surveys and secondary reviews of medical records may occur in years 4-5. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal Government. Applications from minority individuals, women, and persons with disabilities, are encouraged to apply as principal investigators. Foreign applicants are not eligible to apply. SPECIAL REQUIREMENTS Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional offical at the time of award. The reporting requirements, the plans for NCI’s involvement in the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium and the requirements for coordination among investigators from the individual sites are described. Under the cooperative agreement, a partnership will exist between the recipient of the award and the NCI, with assistance from the NCI in carrying out the planned activity. The following terms and conditions pertaining to the scope and nature of the interaction between the NCI and the investigators will be incorporated in the Notice of Grant Award. These terms are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The inability of an awardee to meet the performance requirements set forth in the Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of award. 1. Awardee Rights and Responsibilities A. All awardees All awardees must join the CanCORS Consortium and cooperate fully in the planning and implementation of collaborative projects designed to address research objectives set forth in the RFA. Within this framework, the awardees will have primary and lead responsibility for the project as a whole, including research design and protocol development. Data from the collaborative projects will be pooled for joint analysis, interpretation and publication by Consortium investigators in accord with policies and procedures established by the CanCORS Steering Committee (CSC). Awardees are obligated to adhere to joint decisions for publications and research direction decided on by the CSC. All awardees are required to attend semi-annual meetings to discuss and review scientific and technical aspects of implementation, and analysis and presentation of data results. At least two investigators (including the PI), but no more than four investigators, from each awardee must attend these meetings. The first meeting will be convened by the NCI Program Director and held shortly after initiation of the award. At the initial meeting, Principal Investigators from each of the award recipients will specify the structure and function of a cooperative organizational unit, referred to as the CSC. In order to address the wide range of substantive and methodological issues that may arise during the course of implementation of collaborative protocols, awardees will agree to attend up to two additional small working group meetings per year to facilitate progress on specific analyses, if deemed necessary by the CSC. Awardees are required to provide quarterly reports on progress of special research projects to the CSC, who may then distribute information to other CanCORS investigators as appropriate. B. Primary Data Collection and Research (PDCR) sites PDCR site awardee responsibilities are to: 1. Enroll a minimum number of patients (1,000 per cancer) in order to achieve the overall sample size objectives of the Consortium (6,000 per cancer). Enrollment is defined as obtaining consent for performing inpatient and outpatient medical record reviews from patients or their next-of-kin over the 2-year accrual period. 2. Agree to participate in the Participation Monitoring Committee (PMC) to assist in the specification of performance targets in terms of initial response rates and attrition. These targets will be used by the CSC and PMC as part of their role of ensuring that PDCR sites achieve and maintain high rates of respondent participation. 3. Obtain access to three sources of information vital to core data collection: pathology facilities, cancer patients or their next-of-kin, and institutions and providers who possess records about the patient and the care they received. 4. Adopt a common data collection protocol and use standardized data collection instruments approved by the CSC to ensure uniform procedures across individual site awardees. 5. Accept and implement the common processes and procedures approved by the CSC or its designees for transmitting core data to the Statistical Coordinating Center (SCC). Awardees must submit core data in timely manner to the SCC to ensure such data is available for pooled analyses within the time frame established by the CSC. 6. Assume lead responsibility for the study design, planning, completion of statistical analysis and interpretation of pooled data. 7. Demonstrate a willingness to interact effectively with the SCC, discuss their capability to participate in a consortium of research groups, and state their willingness to help develop and follow the common protocol that will be used to collect core variables. 8. Conduct at least one, and not more than two, special research project(s) that complement core data collection or analysis, but that are separate from the participation in the collection of core data elements. C. Statistical Coordinating Center (SCC) The SCC awardee must also participate actively in all meetings of the CanCORS Consortium and provide scientific, statistical, and technical input into discussions of pooled and collaborative research projects. Specifically, the SCC awardee responsibilities are to: 1. Maintain data comparability processes to be developed by the CanCORS investigators, and improve these processes where needed. 2. Serve as the central repository for pooled data by maintaining confidential and secure mechanisms for transmitting electronic files for core data elements to the SCC. 3. Provide centralized training to patient survey staff and medical record abstraction personnel from the PDCR sites. 4. Examine and report on the quality of submitted data for the purpose of pooled data analysis. 5. Provide data files in ready-to-analyze format (for example, in formats recognized by common statistical packages such as SAS) to the PDCR site investigator(s) responsible for the specific pooled study. 6. Provide the research expertise and collaboration to PDCR site investigators on complex statistical issues for analysis of pooled data. 7. Assume leadership and coordination of regular conference calls of the CSC, and maintaining good communications among all awardees during the term of the project. 8. Conduct at least one, and not more than three, special research project(s) that complement core data collection or analysis. 2. NCI Staff Responsibilities The NCI Program Director will be responsible for normal stewardship of this award, and will also have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. The NCI Program Director will monitor and review the activities of the awardees for relevance to the objectives of the RFA and other programmatic considerations. The NCI Program Director will serve as a member of the CSC, and will designate an additional NCI scientific staff person to serve on the CSC. The NCI Program Director will convene the first of the semi-annual meetings for award recipients to join the CanCORS Consortium. Throughout the term of the project, the NCI Program Director will continue to facilitate and coordinate interactions among the CanCORS awardees to ensure the standardized collection of all core data elements selected by the CSC. The NCI will have access to all data generated under this award consistent with current HHS, PHS, and NIH policies. Periodically, the NCI Program Director or designee will review data management and analysis procedures. The NCI Program Director, or designated NCI scientific staff, will provide information to the awardees about a wide range of data sources and methods used in other studies to complement the design of collaborative projects. The NCI Program Director will call upon other NCI scientific staff as needed to provide advice on specific scientific and technical issues. In addition to normally prescribed duties of program and grants staff, an on-site program review at each awardee site will occur as early as 12 months, but no later than 24 months, after award. The program review will be conducted to evaluate progress of the site in the recruitment of research subjects and collection of core data elements. At least four months prior to these on-site program reviews, specific performance criteria will be provided to sites by the NCI Program Director. These performance criteria will include: minimum target levels of enrollment, survey response rates, access to medical records for reviews, implementation of quality control for collection, storage, and transmittal to the SCC, and study drop-out rates. The minimum accrual targets will be initially developed and proposed by the PMC (without NCI staff involvement in development of review criteria) and approved by the NCI Program Director. 3. Collaborative Responsibilities The CanCORS Steering Committee (CSC) is a committee consisting of the PI’s from each of the PDCR sites, the PI of the SCC, the NCI Program Director, and one person from the NCI scientific staff as designated by the NCI Program Director. The NCI will have one vote. A PDCR site may include an additional representative on the CSC if that site is participating in data collection for both lung and colorectal cancer. The Chair of the CSC will be one of the PI’s as selected by the CSC. The CSC can admit additional non-federal non-voting members as they deem necessary. The CSC will: 1. Be the ultimate decision making body for the CanCORS Consortium, unless a disagreement is brought to arbitration. 2. Establish administrative procedures (i.e., meeting dates, guidelines for reporting, etc.) and methods by which all scientific/analytic requirements of the RFA will be met. 3. Establish or approve collaborative study protocols, core data elements, and instruments to collect core data within a timeframe to be established at the first CanCORS meeting. 4. Approve protocols for special research projects occurring only at one PDCR site or collaborative projects at multiple PDCR sites. The CSC may designate this function to the PMC in order to ensure minimal respondent burden regarding collection of core data elements. 5. Develop policies and procedures regarding publication or presentation of data. 6. Meet separately during the course of the semi-annual CanCORS meetings. It will also meet by conference call at least twice between the semi-annual meetings. 7. Define and establish separate cancer-site specific working groups (for lung and colorectal cancers) if deemed necessary, who would report to the CSC. 8. Establish a CanCORS Working Group (CWG) consisting of persons from outside the Consortium who will provide advice (of its individual members) to the CSC regarding overall strategies, study designs, analysis plans, and results. The CWG will convene at least once each year. The CSC will be responsible for naming members of the CWG and more specifically defining its role. 9. Establish a Data Standards Committee (DSC), which will be responsible for defining the core data elements selected by the CSC or its designees. The DSC will be responsible for assisting and coordinating the collection and reporting of standardized, quality data by all participating sites to the SCC. The DSC will be chaired by the PI of the SCC, and will include other members named by the CSC. Non-federal persons from outside the Consortium may be added to advise the DSC, if such expertise is not available from within the Consortium. 10. Establish a Participation Monitoring Committee, which will be responsible for monitoring the adherence of all research sites to the uniform study protocol established for collection of core data elements, and monitoring patient response rates, attrition, and cooperation of local providers with data collection activities. The PMC members from within the Consortium or from among NCI staff will be named by the CSC. Non-federal persons from outside the Consortium may be added to advise the PMC, if such expertise is not available from within the Consortium. The PMC will identify the most successful protocols for ensuring high participation and low attrition rates, review data on participation and attrition rates as summarized by the SCC, and recommend changes in protocols at PDCR sites if high participation or low attrition rates are not maintained. The non-NCI members of the PMC will also develop performance criteria measures (for example, regarding patient enrollment and retention rates) for approval by the NCI Program Director to be used in conducting on-site program reviews of the individual awardees. These criteria will be developed within 8 months of the initial award. The inability of an awardee to meet the performance requirements set forth in these Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 4. Arbitration Process Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the NCI Program Director. An arbitration panel (with appropriate expertise) composed of one member selected by the awardees, one NCI nominee, and a third member chosen by the other two members will be formed to review the NCI decision and recommend a course of action to the Director, NCI. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI scientific staff. The total project period for applications submitted in response to the present RFA may not exceed 5 years. The anticipated award date is September 1, 2001. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. FUNDS AVAILABLE The NCI intends to commit a total of approximately $6,000,000 in FY 2001 to fund 5 to 12 new competing grants for PDCR sites plus one competing grant for the SCC in response to this RFA, and $8-8.5M in each of years 2-5. The first year amount is smaller than years 2-5 because data collection activities are not anticipated to reach full implementation until year 2. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is anticipated that one award for the SCC will be made for approximately $1,000,000 (including direct and Facilities and Administrative costs) per year, and up to 6 awards to PDCR sites for each cancer site (lung and colorectal) will be made for up to $600,000 (including direct and Facilities and Administrative costs) per year, averaged over the 5-year term of the award. Because a single PDCR site may request additional funds if participating in data collection for both lung and colorectal cancer, the total number of PDCR site awards may be fewer than 12. Special research projects should not exceed 20% of the total budget. Although the financial plans of the NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. NCI has established a CanCORS website which includes answers to frequently asked questions (FAQs) to further assist potential applicants: http://www-dccps.ims.nci.nih.gov/ARP/cancors.html. Direct inquiries regarding programmatic issues to: Arnold L. Potosky, Ph.D. Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, Room 4005, MSC 7344 Bethesda, MD 20892-7344 Telephone: (301) 496-5662 FAX: (301) 435-3710 Email: potosky@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Brian Albertini Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20852 (express courier) Telephone: (301) 496-7239 Fax: (301) 496-8601 Email: albertib@gab.nci.nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 2000, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NCI staff to estimate the potential review workload, and to plan the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed. SCHEDULE Letter of Intent Receipt: October 15, 2000 Application Receipt Date: January 24, 2001 Peer Review Date: May 2001 Review by NCAB Advisory Board: August 2001 Earliest Anticipated Start Date: September 2001 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-mail: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. Specific Instructions for PDCR Site Applications (Core) In proposing objectives, hypotheses, measures, and statistical analysis plans for the core component of the application, each PDCR applicant should assume it is part of the collaborative group of CanCORS awardees and, therefore, is making recommendations that would be considered for adoption by the group as a whole. For example, in the proposed analysis plan pertaining to core objectives, applicants should assume the availability of pooled core data to be collected by all PDCR site awardees. Applications to become a PDCR site within the CanCORS Consortium should include the following components: 1. A statement of objectives, and specific research hypotheses regarding process-outcome relationships for lung and/or colorectal cancer care. Proposed hypotheses should have associated proposed core measures, including important confounding factors such as comorbidity and sociodemographic characteristics, to be collected by all PDCR sites. Background should describe the scientific relevance and the importance of proposed core measures for informing cancer care policies and/or clinical decision making. Examples of general core measures, and suggested topics for disease-specific studies, are available at the CanCORS website http://www-dccps.ims.nci.nih.gov/ARP/cancors.html. 2. Description of population from which eligible cases will be ascertained, and any characteristics of that population regarding access to cancer care that may enhance or limit generalizability. Applicants should provide evidence of socioeconomic diversity of sampled patients treated in diverse health care delivery settings. The minimum number of patients for each cancer (lung and colorectal) to be enrolled is 1,000 (enrollment defined here as obtaining consent for performing inpatient and outpatient medical record reviews from patients or NOK) over a maximum 2-year accrual period. 3. Plans and methods for recruitment and retention of research subjects including the qualifications of the organization(s) for collecting data, and a detailed plan for identifying, acquiring, and transmitting the core data to the SCC. Applicants should also provide: A. Evidence of ability to rapidly enroll newly diagnosed cases as part of epidemiologic or health services studies. Applicants should propose procedures to achieve at least 90% case ascertainment (of all eligible cases) from pathology facilities serving their defined populations within a six month time period following initial diagnosis; B. Methods to conduct mixed mode patient surveys (mailed with phone or in- person follow-up); C. Methods to obtain appropriate consent from patients for medical record reviews, and to obtain record reviews from all relevant providers associated with delivery of cancer-related health care over the course of the disease; D. Methods for conducting comprehensive follow up to measure practice patterns and outcomes in different phases of care including initial treatment, surveillance for recurrence/progression and secondary cancers, treatment for recurrence/progression, and end-of-life care. Special attention should be given to the problems of attrition common to all longitudinal studies, and methods for maintaining a high participation rate among cases and community physicians and other health care providers throughout the duration of the study; E. Plans for obtaining cooperation of patients, next-of-kin, and providers necessary for successful data collection efforts; F. Proposed information technologies or information systems as part of efficiently collecting standardized, core data elements on cancer care practices and outcomes from diverse community medical settings. Applicants may propose development and testing of innovative systems. 4. Description of quality control and assurance procedures for all phases of the research proposed from data collection, storage, transfer and analysis. In addition, it is essential that the level of data quality and quality control of the data source for the sampling frame, such as a cancer registry or other data system, be described. For example, recent descriptions of data quality within cancer registries in North America have been developed by the North American Association of Central Cancer Registries (NAACCR). 5. Plans for addressing the issue of patient confidentiality, including how the records of all research subjects will be protected. The applicant must include evidence and knowledge of legal issues pertaining to the collection and analysis of data. When relevant, specific state and/or federal laws and their impact on the project must be fully explained. 6. A preliminary analysis plan and statistical methods for addressing proposed core research questions or objectives. Applicants are encouraged to propose innovative statistical methods regarding development of new core measures, assessment of patterns of care and associated outcomes in observational settings, and/or survey design. 7. Demonstration of past experience and willingness to participate as a collaborating research partner in Consortium activities, including the collection of timely, consistent, standardized core data elements and reporting of all de-identified information to a central SCC for the purpose of supporting pooled analyses. Applications should be flexible enough to accommodate further refinement and integration with the other awardees for the same organ system. Potential applicants at single research institutions may coordinate with each other to meet minimum accrual targets and may submit common applications. Applicants must include provisions for pilot core data collection during the first year of the award. This will provide the opportunity to evaluate the data collection protocol and methods for data collection and for ensuring high response rates and gaining physician participation and access to patient medical records. The pilot data collection effort may be conducted on small samples of approximately 30-75 patients. Applicants are particularly encouraged in this phase of the project to develop and test innovative information technologies for standardized data collection from community medical practices, as part of collecting either core data or data for special research projects. The page limit for the core research plan component is 25 pages for applicants proposing one cancer, and 35 pages for applicants proposing to study both lung and colorectal cancers. The research plan should address the specific application criteria above using the following topic headings: 1. Research objectives and aims (separate for each cancer if applicable). 2. Background and significance (separate for each cancer if applicable). 3. Suggested core data elements. This section should suggest and justify core measures to be collected to address research objectives, though specific instruments are not required since those must be selected and agreed upon during the first year of the project by consensus. 4. Proposed methods for enrolling and maintaining follow up of study participants. 5. Data collection infrastructure including prior experience, and detailed methods for obtaining, managing, transmitting the core data elements. 6. Preliminary analysis plan with statistical methods for analysis of core research questions. Special Research Projects (non-core studies) Applicants must propose additional special research projects separate from the core data collection component. These projects are smaller studies proposed by individual applicants that complement the collection and/or the analysis and interpretation of core data. Such special studies may include selected samples of patients participating in the core study. Each PDCR site applicant must submit at least one, and not more than two, research plan(s) for special research project(s), separate from the participation in the collection of core data elements to be described in the application. There is an additional five page limit for each additional special research project. Separate budgets should be presented for each non-core special research project. For example, applicants may wish to assess the processes of treatment decision making to better understand the interaction of patient, provider, and institutional factors that may explain reasons for poor dissemination of recommended therapies. This applicant might propose an ancillary study to be conducted within a sub-sample of patients who are enrolled at the time of initial diagnosis, and could thus report directly on factors, including the provider and institutional influences, that affected their decision making. Other examples of special studies may include, but are not limited to: 1. Research on innovative technical approaches for routinely collecting information about cancer care and outcomes; 2. Studies of other factors beyond traditional medical care practices that may be associated with long-term prognosis, such as use of complementary medicines, or modifiable lifestyle factors such as diet, smoking, and physical activity; 3. Utilization of emerging new technologies to treat or manage lung and colorectal cancer patients; 4. The assessment of new prognostic biomarkers of long-term risk through collection of blood or tissue specimens; 5. Proposal of innovative statistical methods for analyzing observational data; 6. Surveys of physician knowledge, attitudes, and practices; studies of health care delivery systems and their impact on cancer care practices. The research plan for special studies is limited to 5 pages per project, and should use the following topic headings: 1. Research objectives and aims 2. Background and significance 3. Research methods and design. Include specific details on how the sample would be drawn from among participants in the core study. 4. Preliminary analysis plan with statistical methods proposed. Specific Instructions for SCC Applications A separate complete application is required from institutions applying to be the SCC for the CanCORS Consortium. Applicants to the SCC component are NOT required to be a PDCR site within the Consortium, though applicants for PDCR sites may also submit an application to be the SCC. The sources of data for this research effort are diverse and range from solo practitioners in rural settings to multi-specialty groups within large, structured managed care organizations in urban settings. The complexity of integrating data from these multiple sources and the increasing use of computerized medical record systems for clinical care necessitates the development of novel data collection and editing systems. Therefore, one key function of the SCC will be to develop automated systems to ensure high quality, efficient reporting of core data from individual PDCR sites to the SCC for eventual use in pooled analyses. Another key function of the SCC will be to support and assist the PDCR sites in their development of standardized, automated data collection methods tailored to their local health care environments. Support for standardization across PDCR site local data collection systems should help to ensure that core data elements are of uniform, high quality across all participating sites. The SCC applicant must describe the approach to soliciting cooperation from the all participating PDCR sites and exercising appropriate leadership in matters of study design, data acquisition, management, and analysis. Applicants for the SCC should propose plans and methods with respect to data management and coordination activities, including: 1. Plans for establishing and evaluating data collection and formatting procedures to create comparable data files for pooled core data. The SCC applicant should demonstrate an understanding of how to create comparable data files from diverse sources and how to link the various subcategories of data being collected for this research effort. 2. Procedures and methods for documenting core data elements and survey questions that are likely to be included as core items in collaborative studies. (see examples at http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.) 3. Plans for working with primary data collection research sites to develop quality control procedures for data collection, storage and transmission of data to the SCC. While primary data collection research sites are responsible for developing site-specific quality control procedures for data collection and storage at their own sites, the SCC will be responsible for working with all research sites to ensure that a standard of data quality is practiced at all sites. The SCC will also be responsible for providing centralized training of survey staff and medical record abstraction personnel from the individual PDCR sites. 4. Detailed procedures for individual research sites to transfer all core data to the SCC using file transfer protocols. The SCC applicant should provide evidence of understanding and experience in creating a central data repository. 5. Procedures to ensure data security, privacy and confidentiality in the transfer process and while the data resides at the SCC. The applicant must include evidence and knowledge of legal issues pertaining to the collection and analysis of data. When relevant, specific state and/or federal laws and their impact on the project must be fully explained. 6. Plans and procedures for coordinating and maintaining regular communications among all the PDCR sites on an ongoing basis. In addition to its central role in moving the CanCORS Consortium towards comparable core data collection, the SCC is intended to accomplish several other research objectives with this initiative, particularly the support and advancement of statistical methodology for studies of process-outcome linkages in community cancer care. Statistical analysis of pooled data is the joint responsibility of investigators from PDCR sites, with collaboration with the SCC as apppropriate. However, the SCC applicant should demonstrate familiarity with key statistical concepts relating to the analysis of observational, population data, such as repeated measures analysis, missing data, hierarchical modeling, and variability across populations, facilities and providers. SCC applicants should discuss the development of an infrastructure for supporting and furthering the development of statistical methods in collaboration with statisticians at the primary data collection sites. In applications, the components of the SCC’s role in facilitating pooled analysis should include: 1. Plans for data management, including formatting, and documentation of core data elements using data dictionaries. 2. Methods for reporting the status of data submitted for pooled data analysis in terms of completeness and utility for pooled analysis. 3. Plans for collaborating with research sites as appropriate to identify or develop statistical methods, and commitment to providing leadership in advancing statistical methodology. The research plan pertaining to the SCC’s role in data coordination and management for the core study is limited to no more than 25 pages, and should use the following topic headings: 1. Research objectives and aims 2. Data management, training, and quality control 3. Analysis and statistical methodology 4. Communication 5. Scientific leadership and dissemination Each applicant to the SCC must submit at least one but not more than three separate research plan(s) for special research projects entailing data collection techniques, or advances in statistical methodology or measurement. There is an additional five page limit allowed to describe the research plans for each of these special projects. If several projects are proposed, separate budgets should be submitted for each one. The research plan for special studies should use the following topic headings: 1. Research objectives and aims 2. Background and significance 3. Research methods and design. Include specific details on how the sample would be drawn from among participants in the core study. 4. Preliminary analysis plan with statistical methods proposed. General Instructions for All Applications Because the Terms and Conditions of Award will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. Each applicant must describe the proposed duties and attendant necessary qualifications required for all other proposed personnel, such as project managers, pathology coordinators, statisticians, data managers, computer programmers, and data entry clerks. Each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. Each applicant should budget for investigators to attend semi-annual meetings over the duration of the 5-year term. In addition, each applicant should budget for hosting two meetings of the CanCORS Consortium investigators over the duration of the 5-year term. A statement of commitment from each participating institution or organization and/or documentation of collaborative arrangements must be provided. Multiple research affiliations and related funded research are permitted, provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing projects will be resolved. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 Applications must be received by January 24, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the National Cancer Institue. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the National Cancer Institute in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The general criteria to be used in the evaluation of grant applications are listed below, followed by specific criteria for primary data collection sites and the SCC. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. The review group will examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. Specific Review Criteria: PDCR Sites The following factors will be considered in evaluating the merit of applications for the PDCR sites: 1. Significance: Scientific, technical, or medical significance and originality of each research project within the application that includes specific proposed core research hypotheses relating processes of lung and/or colorectal cancer care to health outcomes. 2. Approach: Plans and methods for the initial recruitment and retention of subjects, and appropriateness of plans to develop a high-quality data collection infrastructure using multiple data sources including pathology facilities, medical records, patients, and providers. Specifically, reviews should assess the following: A. Availability of a heterogeneous population and health delivery systems for surveillance coverage that complements the proposed research. Adequacy of plans to include minorities and their subgroups, as appropriate for the scientific goals of the research. Plans for enrolling a minimum number of cases (1,000 per cancer type) enrolled over a 2-year accrual period. B. Proposed rapid case ascertainment system to enroll study subjects within the first 6 months following initial diagnosis; linkages available to achieve this through existing cancer registry or other resources. C. Proposed methods for conducting mix-mode patient surveys and medical record reviews from inpatient and outpatient sources of care; D. Proposed methods for retaining subjects over the course of follow-up, and plans for obtaining information about care delivered throughout all phases of cancer care. E. Plans for obtaining cooperation of patients, next-of-kin, and providers such as oncologists, surgeons, radiologists, pathologists, primary care physicians, nurses, and tumor registrars, etc., necessary for successful data collection efforts. F. Plans for development of systems for data collection, formatting and transfer of data to the SCC. G. Procedures for ensuring confidentiality, and quality assurance and control practices to ensure the records and data of all research subjects will be protected. H. Scientific and technical merit of statistical methods for analyses of proposed core research hypotheses. I. Scientific and technical merit of proposed special research studies (non-core). 3. Innovation: Does the project employ novel concepts, approaches or methods with regard to collection of data on process and outcomes of community cancer care? Does the project challenge existing paradigms or develop new methodologies or technologies? Are novel or innovative statistical methods and approaches proposed for analyzing proposed core research hypotheses and data collected within special research projects? 4. Investigators: Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research should include: A. Demonstration of a track record of interdisciplinary activity. B. Experience in the collection of primary data and management of large data sets. C. Personnel with credentials and experience in cancer care health services research, particularly those related to the clinical study of lung or colorectal cancer, epidemiology, biostatistics, data management and computer programming. D. Adequacy of time (effort) that the Principal Investigator and staff would devote to establishing the core database and conducting the proposed studies. 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research; the provisions for the protection of human and animal subjects; and the safety of the research environment. Specific Review Criteria: SCC The following factors will be considered in evaluating the scientific merit of applications for the SCC: 1. Significance: Scientific and technical merit of plans and procedures relating to managing and coordinating collection of core data, support for analysis of pooled data by all CanCORS investigators, and providing leadership in development of statistical methods. 2. Approach: Appropriateness of plans to develop data collection, formatting and transfer practices to conform to standards to be determined by CanCORS investigators for pooled data analysis, specifically: A. Plans for setting up effective data formatting and transfer systems to ensure conformation to standards set by the Consortium and to facilitate pooled data analysis. Plans for development and testing of automated information systems to ensure and facilitate reporting of standardized core data elements by participating research sites to the SCC. B. Planned methods for defining and documenting standardized, core data elements for processes of care from medical records and self-reported data on patient history, quality of life, satisfaction, and other outcomes relevant to the primary research questions; plans for design and development of standard data collection forms to collect core elements determined by the CanCORS Consortium; and procedures for implementing centralized training of all survey and medical abstract personnel. C. Plans and procedures to support the development of uniform quality control procedures for data collection within PDCR sites, and procedures for ensuring quality control of transmitted core data submitted by PDCR sites to the SCC. D. Plans to protect data transmitted and stored at the SCC as part of protection of research subject confidentiality. E. Plans to solicit cooperation and maintain communications among all participating PDCR sites, including a description of planned site visits to PDCR sites to facilitate the collection of core data and conduct of pooled analytic research. F. Scientific and technical merit of statistical methods to be developed and/or applied to analysis of core data. G. Scientific and technical merit of proposed special research studies. 3. Innovation: Scientific significance and originality of: A. Procedures for coordination and quality control of core research data reported to the SCC. B. Statistical methods to measure and analyze the outcomes of cancer care in the community setting. 4. Investigator: Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research should include: A. Demonstration of a track record of interdisciplinary activity, particularly in terms of coordinating large data collection efforts and conducting pooled data analysis. B. Experience in the management of large primary data sets and participation in collaborative studies. C. Personnel with credentials and experience in supporting the activities of the SCC, including biostatistics, computer systems programmer/analyst, and project coordinating and data entry. D. Adequacy of time (effort) that the Principal Investigator and staff would devote to establishing the database and conducting the proposed studies. 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 2001. In the final funding selection process of peer-reviewed and scored applications, NCI program staff will make funding decisions on the basis of the following criteria: 1. Scientific and technical merit as determined by peer review. 2. Appropriateness and duration of the proposed budget in relation to the proposed research. 3. Appropriate mix of minorities and persons of lower socioeconomic status in the core study samples overall, and rural/urban and geographic balance among the primary data collection research sites. 4. Diversity of health care delivery systems with respect to organization and reimbursement within the Consortium as a whole. 5. Availability of funds. Applications recommended by the National Cancer Advisory Board will be considered for award based upon the above criteria. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the updated "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. Because lung and colorectal cancers are diseases of older persons, the research issues under study in this RFA are not relevant to children. Therefore, applicants may use Justification 1: the research topic to be studied is irrelevant to children; from the policy announcement. The following information is provided to ensure that all NIH applicants are aware of the policy. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, Cancer Care Outcomes Research and Surveillance Consortium, is related to the priority area of cancer surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES . Breslow L, Bailar JCI, Brown BW, Brown HG, Darity WA, Defendi V, et al. Measurement of progress against cancer. JNCI 1990. 82:825-835. 2. Hewitt M and Simone JV, eds: Ensuring Quality Cancer Care. National Cancer Policy Board, IOM. National Academy Press, Washington, D.C. 1999. http://books.nap.edu/catalog/6467.html


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