QUICK-TRIALS FOR NOVEL CANCER THERAPIES
  
Release Date:  January 27, 2000

PA NUMBER:  PA-00-047

National Cancer Institute
National Center for Complementary and Alternative Medicine

Letter of Intent Receipt Date: One month prior to application receipt date
Application Receipt Dates: April 9, August 9, December 9 through August 9, 
2002

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

Continuing advances in molecular genetics and drug development have led to 
new approaches for inhibiting tumor growth either directly or by impacting 
the tumor microenvironment.  These agents include new classes of cytotoxic 
agents, agents or approaches that act via immune-stimulatory effects, agents 
that inhibit angiogenesis and metastasis or alter signaling pathways, and 
agents targeted specifically to novel cancer cell targets.  At present, there 
is a paucity of funding mechanisms targeted to stimulate the transition of 
promising and potentially relevant advances in new drug development from the 
laboratory into the clinical setting for the treatment of early and advanced 
disease.  Similarly, there are limited means to support rigorous evaluations 
of complementary and alternative medicine (CAM) treatments for cancer, such 
as botanicals, unconventional pharmacological and biological interventions, 
or mind-body approaches.

The QUICK-TRIAL program was initially published as a pilot program in 
prostate cancer.  This Program Announcement (PA) sponsored by the National 
Cancer Institute and the National Center for Complementary and Alternative 
Medicine expands the initiative to all cancer sites and provides 
investigators with rapid access to support for pilot, phase I, and phase II 
cancer clinical trials testing new agents and patient monitoring and 
laboratory studies to ensure the timely development of new therapeutic 
approaches.  QUICK-TRIAL will provide a new approach designed to simplify the 
grant application process and provide a rapid turnaround from application to 
funding.  Features include a modular grant application and award process, 
inclusion of the clinical protocol within the grant application, and 
accelerated peer review with the goal of issuing new awards within five 
months of application receipt.  Inclusion of the complete clinical protocol 
within the PHS 398 grant application is intended to simplify the application 
process by eliminating the need to duplicate protocol details in the Research 
Plan section. Investigators may apply for a maximum of two years of funding 
support using the exploratory/developmental (R21) grant mechanism for up to 
$250,000 direct costs per year.

This PA supersedes and replaces both PA-99-070, Quick Trials for Prostate 
Cancer Therapy, published in the NIH Guide for Grants and Contracts, March 5, 
1999, and PAR 97-006, Small Grants for Therapeutic Clinical Trials of 
Malignancies, published in the NIH Guide for Grants and Contracts, Vol. 25, 
No. 37, November 1, 1996.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," a 
PHS-led national activity for setting priority areas.  This PA, QUICK-TRIALS 
for Novel Cancer Therapies, is related to the priority area of cancer.  
Potential applicants may obtain a copy of "Healthy People 2000" at 
http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and 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.  Racial/ethnic minority individuals, 
women, and persons with disabilities as well as new clinical investigators 
are encouraged to apply as principal investigators.  An application may 
include one or more institutions (e.g., individual institutions, consortia, 
cancer centers) with established clinical, laboratory, and statistical 
resources.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health 
(NIH) exploratory/developmental grant (R21) mechanism.  The exploratory/ 
developmental (R21) grant mechanism is utilized for pilot projects or 
feasibility studies to support creative, novel, high risk/high payoff 
research that may produce innovative advances in science. The exploratory 
grant program provides support for short-term (up to two years) research 
projects.  Applications submitted in response to this PA will be limited to 
$250,000 direct costs per year (includes third party facilities and 
administrative costs).  These grants are non-renewable, and continuation of 
projects developed under this program will be through the traditional 
unsolicited investigator-initiated research grant program.

Applicants will be responsible for the planning, direction, and execution of 
the proposed project.  All PHS and NIH grants policies will apply to 
applications received and awards made in response to this program 
announcement.  The total project period for applications submitted in 
response to this PA may not exceed 2 years.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

For this PA, funds must be requested in $25,000 direct cost modules. A 
feature of the modular grant is that no escalation is provided for future 
years, and all anticipated expenses for all years of the project must be 
included within the number of modules being requested.  Only limited budget 
information is required and any budget adjustments made by the Initial Review 
Group will be in modules of $25,000.

RESEARCH OBJECTIVES

Background

With advances in our understanding of the basic biology of cancer, tumor 
immunology, and the molecular genetics of cancer, new approaches for 
inhibiting tumor growth either directly or by impacting the tumor 
microenvironment have been identified.  Novel drug therapeutics based on 
these new approaches are ready to be tested in the clinic with new tools and 
laboratory analyses that allow investigators to ascertain how specific 
targets are affected by therapy.  These approaches include new classes of 
cytotoxic agents, agents acting via immune-stimulatory effects, agents that 
inhibit angiogenesis and metastasis or alter signaling pathways, and agents 
targeted specifically to novel cancer cell targets.  New clinical therapeutic 
trials may employ drugs, biologics, radiation, or surgery used as single 
agents/modalities or in combination for the treatment of early and advanced 
disease.  In addition, clinical trials of CAM therapies for cancer  
treatment, including, but not limited to, mind-body approaches (e.g., 
relaxation, imagery, meditation, psychosocial support groups, or 
psychotherapy, etc. ), herbal therapies, dietary supplements, or 
unconventional pharmacological and biological interventions (e.g., 
antineoplastons, Coley’s toxin, enzyme therapies, etc.) will be considered.

At present, there are few funding mechanisms targeted to stimulate the 
communication of promising and potentially relevant advances in new drug 
development from the laboratory into the clinical setting.  Quite frequently 
the initial stages of clinical investigation are the most difficult to 
accomplish.  They are resource intensive, and to be done well they require 
laboratory, pharmacology, and other resource support, as well as substantial 
personnel effort, none of which is supported by health benefit programs.  
Nonetheless, these early studies tend to fare poorly in competition for 
conventional grant support precisely because they are preliminary and cannot 
serve as the definitive tests of new approaches.  Even when funding is 
received, the review and award cycle may introduce a year or more of delay.  
Except where there is an industrial sponsor with a particular commitment to 
development of an agent, it may take a long time for a promising approach to 
get through the initial phase of demonstrating feasibility and interest, or 
it may never be tested in more than one or two diseases.  NCI recently 
published a new initiative entitled Rapid Access for Intervention Development 
or RAID (http://dtp.nci.nih.gov) to support the clinical development of new 
agents by providing access to NCI resources for toxicity studies and 
formulation and production of new agents for clinical use.  The QUICK-TRIAL 
program will serve as an extension of RAID by providing a new initiative with 
accelerated peer review and funding to support the clinical and laboratory 
costs of early clinical testing to ensure the timely development of new 
therapeutic approaches.

Objectives and Scope

The aim of this initiative is to support pilot, phase I, and phase II 
clinical trials and associated patient monitoring and laboratory studies for 
the treatment of malignancies using novel therapeutic approaches.  
Therapeutic trials in human subjects employing new agents and therapeutic 
approaches, including CAM treatments, whether used as a single agent/modality 
or in combination, are appropriate.  Preference will be given to clinical 
trials that include laboratory studies to validate mechanistic hypotheses or 
clinical correlates that can meaningfully guide further clinical development.  
The QUICK-TRIAL program may therefore serve as a extension to the RAID 
program but may also be used by applicants whose agents have emerged from 
industry development programs, where support may only be needed for 
mechanistic and correlative laboratory studies.

Applicants to the QUICK-TRIAL program may request support for the conduct of 
either the clinical trial, the proposed laboratory studies, or both.  Whether 
the studies are focused on the clinical trial or laboratory studies, the 
grant application package must include the complete clinical protocol in the 
Human Subjects section of the grant application.  Including the protocol as 
the major part of the QUICK-TRIAL application is intended to save the 
applicants the significant additional labor of repeating the details of the 
trial in the body of the grant application.  Where support is sought for the 
actual clinical trial, the protocol should be authored by the investigators 
applying for QUICK-TRIAL support.  In cases where the investigator seeks 
support only for laboratory studies to accompany a trial funded by a company, 
a protocol written by the drug sponsor or other clinical investigators is 
acceptable.

Support for the conduct of the clinical trial and/or patient monitoring and 
correlative laboratory studies that have clinical relevance to the 
therapeutic clinical trial may be requested.  A rigorous description of the 
rationale and methodology for the laboratory components of the study, as well 
as a description of how the results will be analyzed in conjunction with the 
results of the clinical trial, should be provided.  Laboratory studies using 
patient specimens from the clinical trial may include patient monitoring 
studies (i.e., pharmacokinetics, immune response, etc) or clinical 
correlative studies that may guide clinical development of the new agent or 
approach or identify patient subsets for specific therapies.  Laboratory 
studies of  the underlying mechanisms of intervention, the mechanisms of 
disease pathogenesis, or surrogate markers of disease activity and 
therapeutic effect are encouraged.  Statistical design issues should be 
addressed in the research plan for both the clinical protocol and the 
laboratory analyses.  The proposed research plan should convince reviewers 
that the planned studies are well conceived, that the methodology is solidly 
grounded and practical for use in a clinical trials setting, and that the 
analysis plan is sensible and likely to be informative.

In order to review and confer awards to applications received in response to 
this PA in a timely fashion without delay of the clinical trial, NCI and CSR 
have developed a pilot project for accelerated review/award.  QUICK-TRIAL 
will provide a new approach designed to simplify the grant application 
process and provide a rapid turnaround from application to funding.  Features 
include a modular grant application and accelerated peer review with the goal 
of issuing new awards within five months of application receipt.  
Investigators may apply for up to two years of funding support.  It is 
expected that patient accrual will be completed within the two year funding 
period even though final patient outcome analysis may not occur for 1-2 years 
later.  In order to permit rapid turnaround of the grant applications, IRB 
approval must be obtained prior to review of the grant application.  If FDA 
IND approval is needed, documentation of IND submission must be included in 
the grant submission.  Investigators who intend to use NCI sponsored drugs 
must submit a Letter of Intent (CTEP LOI) to the Cancer Therapy Evaluation 
Program, NCI, (http://ctep.info.nih.gov/IDB) prior to grant submission.  The 
CTEP LOI for requesting drugs should mention your plans to submit a grant 
application for this PA.  An approval letter from CTEP confirming potential 
drug availability must be received prior to grant submission.  This is to 
insure availability of sufficient quantities of drug and to avoid 
unjustifiable duplication of studies already in progress.

Because the QUICK-TRIAL program is designed to support novel and innovative 
ideas and utilizes the exploratory grant mechanism, preliminary data as 
evidence of feasibility are not required.  However, the applicant does have 
the responsibility for providing a convincing rationale and justification for 
the proposed  developing a sound research plan.  Originality of approach and 
potential significance of the proposed research are major considerations in 
the evaluation.

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 subpopulations 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 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 20, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, 
Volume 23, Number 11, March 18, 1994 available on the web at the following 
URL address:   
http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

Investigators also may obtain copies of  the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.  

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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 also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, one month before the application 
receipt date, a letter of intent that includes a descriptive title of the 
proposed research, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, and the number and title of the PA 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 a subsequent 
application, the information that it contains allows NCI staff to estimate 
the potential review workload and avoid conflict of interest in the review.  
The letter of intent is to be sent to Ms. Diane Bronzert at the address 
listed under INQUIRIES.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contact listed 
under INQUIRIES with any questions regarding their proposed project.

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  Applications are to be submitted on the grant application form PHS 
398 (rev. 4/98).  Applications will be accepted on the 9th of April, August, 
and December through August 9, 2002.  Amended applications are due on the 
same receipt dates.  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 
301/435-0714, Email:  grantsinfo@nih.gov.  Application kits are also 
available at: http://grants.nih.gov/grants/forms.htm.

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 (see  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).

SEE SPECIFIC APPLICATION INSTRUCTIONS BELOW FOR MODULAR GRANT APPLICATIONS.

Submit a signed, typewritten original of the application, including the 
checklist, and five signed, exact, single-sided photocopies, in one package 
directly to Dr. Suzanne Fisher at the address listed below.

PLEASE NOTE THAT THIS ADDRESS IS DIFFERENT FROM THE INSTRUCTIONS IN THE 398 
APPLICATION PACKAGE AND FAILURE TO COMPLY WILL RESULT IN DEFERRAL OF REVIEW.

SUZANNE E. FISHER, PH.D.
DIVISION OF RECEIPT AND REFERRAL
CENTER FOR SCIENTIFIC REVIEW
6701 ROCKLEDGE DRIVE, ROOM 2030, MSC 7720
BETHESDA, MD  20892-7720
BETHESDA, MD  20817 (for express/courier service)

SPECIFIC APPLICATION INSTRUCTIONS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year. The total direct costs 
must be requested in accordance with the program guidelines and the 
modifications made to the standard PHS 398 application instructions described 
below:

o  FACE PAGE: The title and number of the program announcement must be typed 
in line 2 on the face page of the application and the "YES" box must be 
marked.  Investigators without prior R29 or R01 support are encouraged to 
apply for this PA and to identify their status as a new investigator on the 
front of the grant application.  IRB approval must be obtained prior to 
review of the grant application or it will be deferred.  Items 7a and 7b 
should be completed, indicating Direct Costs (in $25,000 increments) and 
Total Costs [Modular Total Direct plus Facilities and Administrative (F&A;) 
costs] for the initial budget period.  Items 8a and 8b should be completed 
indicating the Direct and Total Costs for the entire proposed period of 
support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative 
page. See http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages. At the top of the page, enter the total direct costs requested for 
each year.

o  Under Personnel, list key project personnel, including their names, 
percent of effort, and roles on the project. No individual salary information 
should be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of key personnel, 
and the role on the project.  The total cost for a  consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.  If large patient care costs or drug acquisition  
costs are needed and require additional modules, provide a narrative budget 
justification documenting budget costs.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:  http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  RESOURCES - A description of both the clinical and laboratory facilities 
and resources should be included in the grant application.  This includes 
detailed information on plans for data management, quality control of patient 
and laboratory data, and computer resources and plans for handling both 
laboratory and clinical data.  If Cancer Center cores will be used for these 
tasks, letters of support from the appropriate individual with authority to 
commit the needed resources should be included in the application.  Provide 
information on resources provided by the drug sponsor if not at your 
institution.

o RESEARCH PLAN - Applications in response to this PA should be concise and 
substantially shorter than regular grant applications.  ITEMS a-d MAY NOT 
EXCEED 15 PAGES IN TOTAL.

Item a - Specific Aims - In one page or less, list in priority order, the 
broad, long-range objectives.  Describe concisely and realistically the 
hypothesis to be tested and what the specific research described in this 
application is intended to accomplish.

Item b - Background and Significance - In two pages or less, use this section 
to describe (a) how the proposed research will contribute to meeting the 
goals and objectives of the PA; and, (b) explain the rationale for the 
selection of the general methods and approaches proposed to accomplish your 
specific aims.  Describe the significance of the planned studies and consider 
how the pilot study, if encouraging, could transition into an eventual 
definitive test of the therapeutic approach.  Describe the innovative aspects 
of the studies including novel concepts, approaches, or methodologies.  Do 
not include background material provided in the clinical protocol document 
but you may refer to the appropriate sections/pages of the protocol.

Items c-d - Progress Report/Preliminary Studies, Research Design and Methods 
- In twelve pages or less, complete as instructed in the PHS 398 booklet.  TO 
THE EXTENT THAT MATERIAL INCLUDED IN THE CLINICAL PROTOCOL IS ADEQUATE FOR 
REVIEW, IT NEED NOT BE REPEATED IN THIS SECTION.  (The clinical protocol must 
be included in the Human Subjects section even if support is only requested 
for laboratory studies.) The investigator may use this section to address the 
following:

o  Preliminary studies pertinent to the application;

o  Rationale and hypothesis for the clinical trial and laboratory studies.

o General methods that will be utilized, clinical, laboratory, or both, as 
appropriate; reason(s) for selecting these approaches; provide specific 
details for those techniques which are unique or where a significant 
departure from a generally accepted technique is important for reviewers to 
know;

o  Outcome measures that will be used to assess the success or failure of 
each set of experiments (include statistical analyses for laboratory and 
clinical studies); clinical endpoints should be discussed with particular 
emphasis on those aspects that may be especially complicated in clinical 
trials (e.g., lack of conventionally measurable disease; patients whose only 
evidence of disease is biochemical).

o  A statistical section should be included discussing the choice of the 
clinical trial design and  laboratory analyses with power calculations.  The 
statistician involved with the study should be identified and a letter of 
support included if no effort is requested on the grant application.  Plans 
for data management and verification of research data should also be 
included.

o  Potential pitfalls in the experimental design and alternative studies that 
will be done if the proposed experiments fail. 

The Research Plans must include the following sections:

Gender and Minority Inclusion for Research Involving Human Subjects - 
Describe the composition of the proposed study population in terms of gender 
and racial/ethnic group and  provide a rationale for selection of such 
subjects.  Display this proposed composition using the Inclusion Report 
Format provided in the PHS 398 form instructions. 

Participation of Children - This section should provide either a description 
of the plans to include children and a rationale for selecting or excluding a 
specific age range of child, or an explanation of the reason(s) for excluding 
children as participants in the research (see justifications for exclusions 
in the PHS 398 form instructions).

o HUMAN SUBJECTS -  IN ADDITION TO THE INFORMATION REQUESTED IN THE PHS 398 
FORM, INCLUDE THE COMPLETE CLINICAL PROTOCOL IN THIS SECTION  Informed 
consent form(s) must be included.  NIH will treat as confidential any 
scientific, preclinical, clinical, or formulation data and information that 
the sponsor deems to be proprietary and confidential.  

IN ADDITION, applicants must insure that the first page of the human subjects 
section includes the following information:

1a)  If NCI-provided agent(s) to be used:  CTEP-assigned LOI # and date of 
CTEP LOI response letter confirming potential availability__________

1b)  If agent(s) will be provided by a company, letter is provided confirming 
plans to provide agents and date available__________

1c)  If this protocol is an initial IND-filing study:  date IND submitted to 
FDA__________

1d)  None of the above (1a, 1b, or 1c) applies__________

NCI/CTEP or drug company correspondence should be included in the Appendix, 
as applicable.

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A; rate agreement has been established, indicate the 
type of agreement and the date. It is important to identify all exclusions 
that were used in the calculation of the F&A; costs for the initial budget 
period and all future budget years.

o APPENDIX - Include a maximum of 10 publications, manuscripts (submitted or 
accepted for publication), abstracts, patents, or other printed material 
relevant to this project.  Include letters from appropriate drug sponsor.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

Applications not conforming to these guidelines will be considered 
unresponsive to this PA and will be returned without further review.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened by the Center for 
Scientific Review in accordance with the standard NIH peer review procedures.  
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 applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by either the National Cancer Advisory Board or the 
National Advisory Committee for Complementary and Alternative Medicine.

Review Criteria

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.

1. Significance.  Does this study address an important problem?  If the aims 
of the application are achieved, will this be a worthwhile experiment in 
investigating an innovative therapeutic approach?  How will scientific 
knowledge be advanced?  What will be the effect of these studies on the 
concepts or methods that drive this field?

2. Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Have the investigators considered how the pilot study, 
if encouraging, could transition into an eventual definitive test of the 
therapeutic approach?

3.  Innovation.  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative? Does the project challenge 
existing paradigms or develop new methodologies or technologies for cancer?

4.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

5.  Environment.  Are the planned statistical and data management resources 
adequate?  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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include minorities and their subgroups as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Ms. Diane Bronzert or Dr. Roy Wu
Program Directors, Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663
Email:  db85g@nih.gov or rw51j@nih.gov

Dr. Richard L. Nahin
Division of Extramural Research
Training and Review
National Center for Complementary and Alternative Medicine
9000 Rockville Pike
Bldg. 31, Room 5B-58
Bethesda, MD 20892-2182
Telephone: 301-496-4792
Email: NahinR@OD.NIH.GOV

Direct inquiries regarding fiscal matters to:

Ms. Jill Rogers
Grants Management Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-8699 
FAX:  (301) 496-8601
Email: rogerj@gab.nci.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No 
93.395, Cancer Treatment Research and 93.213, Complementary and Alternative 
Medicine Research.  Awards are made under the authorization of the 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 and contract 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.


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