Full Text CA-92-12

CLINICAL CORRELATIVE STUDIES IN SOLID TUMORS

NIH GUIDE, Volume 21, Number 11, March 20, 1992

RFA:  CA-92-12

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Chemotherapy 
  Therapy Evaluation 
  Diagnosis, Medical 


National Cancer Institute

Letter of Intent Receipt Date:  May 29, 1992
Application Receipt Date:  July 10, 1992

PURPOSE

The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer
Treatment (DCT) and the Cancer Diagnosis Branch (CDB) of the Division
of Cancer Biology, Diagnosis and Centers (DCDBC) at the National Cancer
Institute (NCI) invite applications for cooperative agreements (U01)
from institutions or consortia, such as DCT Clinical Trials Cooperative
Groups, capable of and interested in performing clinical correlative
studies with new prognostic factors ready for large scale evaluation.
These factors must be relevant to the cancer treatment or clinical
outcome of patients with solid tumors.  It is essential for
institutions to have access to sufficient numbers of patients on phase
III clinical protocols to be able to test correlative hypotheses.
Solid tumors that account for significant cancer incidence, morbidity
and mortality, e.g., breast, prostate, lung, colon-rectum, upper
aerodigestive, ovary, bladder, pancreas, melanoma, stomach, kidney, as
well as rarer tumors such as pediatric and adult brain and sarcoma, are
relevant to this Request for Applications (RFA).

Awards will be made as cooperative agreements which create an
assistance relationship with substantial NCI programmatic involvement
with the recipients during the performance of the project, as outlined
in this RFA.  The cooperative agreement mechanism is used when the NCI
wishes to stimulate investigator interest and proposes to advise or
assist in an important and opportune area of research.  The NCI
anticipates making 10 to 12 awards for project periods of up to four
years.  A total of $2,000,000 is expected to be set aside for funding
these activities in the initial year.  Although this project is
provided for in the financial plans of the NCI, the award of
cooperative agreements pursuant to this RFA is contingent on the
availability of funds appropriated in fiscal year 1993.

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 RFA,
Clinical Correlative Studies in Solid Tumors, is related to the
priority area of cancer.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit and for-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 may be
submitted from one institution or may include arrangements with one or
more additional institutions, if appropriate.  Applications from
minority individuals and women are encouraged.

It is essential for Teams to have access to sufficient numbers of
patients on phase III clinical protocols to be able to test correlative
hypotheses.  The Study Team must have access to a Central Operations
Office and a Statistical Center for coordination of research activities
and data analysis as defined above (see Definitions).  The Central
Operations Office and the Statistical Office need not reside at the
PI's Institution.

MECHANISM OF SUPPORT

Support of this program will be through the Cooperative Agreement
(U01), an assistance mechanism in which substantial NCI programmatic
involvement with the recipient during performance of the planned
activity is anticipated.  The nature of NCI staff involvement is
described in Section VI.  Applicants will be responsible for the
planning, direction, and execution of the proposed project.  Except as
otherwise stated in this RFA, awards will be administered under PHS
grants policy as stated in the Public Health Service Grants Policy
Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1,
1990.

This RFA is a one-time solicitation.  However, should it be determined
that there is a sufficient continuing program need, the NCI will invite
recipients of awards under this RFA to submit competitive continuation
cooperative agreement applications for review according to the
procedures described in Review Considerations.

FUNDS AVAILABLE

Approximately $2,000,000 in total costs per year for four years will be
committed to specifically fund applications submitted in response to
this RFA.  It is anticipated that ten to twelve awards will be made.
This funding level is dependent on the receipt of a sufficient number
of applications of high scientific merit.  The total project period for
applications submitted in response to the present RFA may not exceed
four years.  Although this program is provided for in the financial
plans of the NCI, the award of grants pursuant to this RFA is also
contingent upon the continuing availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Insights into the biologic function and clinical relevance of growth
factors, genes that promote and suppress neoplasia, mechanisms of
treatment sensitivity and resistance, and functions of the immune
system provide important new clinical research opportunities for
investigators studying patients with solid tumors.  While advances have
been made relating biological studies to clinical behavior of
hematologic malignancies, fewer clinical correlations have been
explored for solid tumors. Historically, prognostic factors have played
a major role in assisting clinicians in the selection of appropriate
therapeutic interventions.  In the case of breast cancer, estrogen
receptor and progesterone receptor status are now commonly used as
prognostic and treatment indicators.  Currently, several well defined
laboratory tests are ready for inclusion in clinical correlative
studies to determine their clinical relevance and value.  For example,
HER-2/neu, cathepsin D and stress response proteins are currently being
evaluated in adjuvant breast cancer studies.  New technological
advances in methodologies such as Polymerase Chain Reaction (PCR), flow
cytometry, immunohistochemistry, and in situ hybridization allow
laboratory investigators to do numerous analyses on tumor specimens and
study tumor heterogeneity in a variety of tumor types.  Many
opportunities exist for conducting correlative laboratory studies that
can be expected to be immediately relevant to cancer treatment.

The NCI supports an extensive network of clinical and laboratory
research studies related to cancer therapy through contracts, grants
and cooperative agreements.  CTEP supports a program of integrated
national networks of clinical investigators and institutions (Clinical
Trials Cooperative Groups) for the conduct of large scale,
multi-institutional clinical trials.  The primary goal of these trials
is the definitive evaluation of clinical treatment programs.
Presently, the Clinical Trials Cooperative Groups (CTCG) conduct
approximately 500 clinical trials evaluating more than 23,000 patients
per year.  The CTCG have access to tumor specimens from large numbers
of patients with solid tumors.  They maintain statistical databases and
are capable of correlating laboratory data with the clinical outcome of
patients.  NCI also supports Cancer Centers at which phase III clinical
trials are conducted and access to statistical operations,
headquarters, and consortia arrangements with other institutions and
hospitals exist.

This RFA is designed to promote collaborations and interactions between
basic researchers and clinical investigators to advance research on
clinical correlations that can improve therapeutic approaches.  NCI is
seeking to encourage correlative laboratory studies linked to large
scale clinical trials.  In many instances the laboratory investigators
are already recipients of R01 or P01 support for basic research and
have developed preliminary data supporting a large scale analysis of a
new prognostic factor.  Likewise, many clinical investigators are
supported through Cancer Centers (P30) and the Clinical Trials
Cooperative Group mechanism (U10) for clinical research and have access
to patient specimens with clinical follow-up.  This initiative proposes
to link these activities and provides a mechanism to obtain definitive
data on the relationship of biological features and the clinical
behavior of the tumors.

Research Goals and Scope

The objectives of this RFA are to foster collaborations and
interactions between basic researchers and clinical investigators to
advance therapeutic clinical research and conduct correlative studies
in solid tumors on new prognostic factors that are ready for large
scale evaluation.  The CTEP and the CDB invite cooperative agreement
applications (U01) from institutions or consortia, such as the DCT
Clinical Trials Cooperative Groups and the NCI Cancer Centers, capable
of and interested in performing clinical correlative studies relevant
to cancer treatment or clinical outcome in patients with solid tumors.

Solid tumors relevant to this RFA account for significant cancer
incidence, morbidity and mortality, e.g., breast, prostate, lung,
colorectal, upper aerodigestive, ovary, bladder, pancreas, melanoma,
stomach, kidney, as well as rarer tumors such as pediatric and adult
brain and sarcoma.  Applicants may propose to undertake several
correlative studies relevant to the specific solid tumor during the
grant funding period (up to four years).  An individual scientist or a
consortia of institutions may be included on more than one application.

The correlative studies should be based on strong and testable
hypotheses.  A clear rationale should be given for the experimental
design and technical methodologies selected.  The hypotheses tested
must relate to potential clinical applications such as development of
new treatment strategies or identification of patient subsets for
specific treatment approaches.  Preliminary data from appropriate tumor
models or analysis of patient specimens should be provided to support
the feasibility of each study.  This RFA is for developing assays that
have already been demonstrated to be applicable to tissue samples
and/or body fluids.  The laboratory assays must utilize tumor specimens
from patients receiving defined treatments in large clinical trials
such as phase III clinical protocols.  Proposals must include a
statistical section describing plans for analysis of data designed to
test the hypotheses.  Applications will be considered responsive only
if investigators have access to sufficient numbers of patient
specimens.  All investigators are encouraged to work with multi-center
organizations or form a consortium of institutions in order to access
sufficient numbers of patients and clinical information to test the
proposed hypotheses.  To coordinate the above activities, each Team
must have a Central Operations Office and Statistical Center as defined
above (see Definitions).

Examples of therapeutic laboratory correlates of interest include, but
are not limited to:  (1) phenotypic or genotypic alterations that
appear to correlate with the development of drug-, radiation or hormone
resistance; (2) loss or inactivation of tumor suppressor genes related
to prognosis; (3) analysis of basal membrane factors related to tumor
invasion and metastases; (4) studies of chromosomal rearrangements or
deletions that may be used as prognostic indicators; (5) correlation of
tumor growth factors or oncogenes with response to therapies; (6)
characterization of tumor associated antigens that may lead to new
immunotherapies; and (7) evaluation of use of serum or tumor markers
that correlate with tumor progression.

The cooperative approach outlined in this RFA permits interactions
among successful applicants and is designed to optimize use of patient
resources, tissues, reagents and methods.  Applicants must describe how
they might interact with NCI and other awardees in the sharing of data
and improvements in laboratory techniques and study design
methodologies.

SPECIAL REQUIREMENTS

DEFINITIONS

COOPERATIVE AGREEMENT - An assistance mechanism in which substantial
NCI programmatic involvement with the recipient is anticipated during
performance of the planned activity.

STUDY TEAM - A Study Team may be a single institution or a consortium
of institutions.  A Study Team functions as an integrated unit with a
common goal and is under the guidance and direction of a single
Principal Investigator.  Each Study Team is composed of investigators
with expertise in clinical investigations and laboratory analyses.
Each Study Team must have access within its institution or consortia to
an Operations Office and Statistical Center.  In this RFA, the terms
Study Team and Team are used synonymously.

PRINCIPAL INVESTIGATOR (PI) - The person who submits the single
application in response to this RFA and who is responsible for
performance of the key personnel and the Study Team as a whole. A
consortium of institutions must agree to work together with a single
Principal Investigator under a single cooperative agreement.  The
Principal Investigator is responsible for coordinating the Study Team's
activities scientifically and administratively.

CENTRAL OPERATIONS OFFICE - An administrative unit that coordinates all
Team activities.  Responsibilities include coordinating protocol
development, study conduct, and quality control and study monitoring.
Each Study Team must have a Central Operations Office but it need not
be at the PI's institution.

STATISTICAL CENTER - The Study Team must have a Statistical Center for
collection and analysis of patient and laboratory data.
Responsibilities will include participation in the planning and
coordination of study design methodologies, data management and
analysis, data monitoring, and reporting of data. Each Study Team must
have a Statistical Center but it need not be at the PI's institution.

NCI PROGRAM DIRECTORS - The CTEP staff member from the Divison of
Cancer Treatment and the CDB staff member from the Division of Cancer
Biology Diagnosis and Centers who will be coordinating the interactions
of the Divisions and providing guidance for the overall program within
the NCI.

NCI COORDINATOR - The senior staff member who interacts scientifically
with the Team.  Teams funded for research on the same type of solid
tumor will be assigned the same NCI Coordinator.  The Program Director
may also serve as the NCI Coordinator for a Team.

TERMS OF COOPERATION

The cooperative agreements will require cooperation between an NCI
Coordinator and the Principal Investigators of the Teams.  The NCI
Coordinator will assist in coordinating the activities of the Teams as
defined below and in facilitating exchange of information.

NATURE OF PARTICIPATION BY NCI STAFF

The role of the CTEP and CDB staff as described throughout these terms
of cooperation is to assist and facilitate, but not to direct, research
activities.  An NCI Coordinator will be selected from the CTEP or CDB
Staff for each Team or Teams working on the same disease.  Two levels
of coordination are anticipated.

The first level involves interactions between the NCI Coordinator and
the individual Team.  During the period of the award, the NCI
Coordinator may provide appropriate assistance by participating in the
design of research activities, review of protocols, coordination of the
tissue utilization, establishment of priorities, and review of
progress.  The NCI Coordinator can assist in this process by providing
information on other ongoing studies and on NCI priorities.  Protocols
will be provided to the CTEP Protocol Review Committee and the
Diagnosis Decision and Implementation Committee for review to
facilitate coordination of research activities throughout NCI.
Although the Team(s) are responsible for statistical analysis of the
data, computer processing and statistical evaluations may be provided
from NCI resources upon recommendation of the NCI Coordinator.

The second level of coordination involves interactions between the NCI
Coordinator and Teams funded for research on the same solid tumor.  It
is expected that Teams working on the same tumor will participate in
joint activities.  The NCI Coordinator will coordinate activities among
the Teams such as the sharing of patient specimens, new reagents,
improved laboratory techniques, data, and study design methodologies.
Although investigators will have to demonstrate that they have access
to the necessary numbers of patients and/or specimens to answer
specific questions, other important correlations identified during the
course of the funded research may require patient resources from more
than one Team.  Priorities would need to be set for the most effective
use of available specimens since tumor specimens are often small in
size.  The NCI Coordinator can assist in this process by providing
information on other ongoing studies and on NCI priorities.

RESPONSIBILITIES OF AWARDEES

The Study Team is responsible for proposing research projects to
advance the goals of the RFA and to define the approaches to attain
these goals.  It is the primary responsibility of the PI to state
clearly the objectives of the Team, to direct the research stipulated
in the application, and to ensure that the results obtained are
published in a timely manner.  It is anticipated that decisions in all
activities will be reached by consensus of the collaborators of a Team
under the leadership of the PI and that the NCI Coordinator will have
the opportunity to contribute to this process.  Awardees are required
to have access to appropriate tumor tissue and clinical follow-up on
patients receiving defined treatments in phase III clinical trials.
Awardees must have the appropriate clinical and laboratory expertise to
accomplish the objectives of the Study Team.

For each solid tumor research area for which only one award is made,
the Awardee and the NCI Coordinator will meet initially to discuss
research plans and establish priorities.  Subsequent periodic meetings
will be scheduled to review progress and coordinate new research
activities.  The NCI Coordinator and the Awardee will plan to hold at
least one meeting per year.

It is envisioned that more than one award may be made for research on
some types of solid tumor.  For these Awardees, sharing of data and
reagents will be expected.  In addition, new studies that may require
the sharing of patient specimens and the prioritization of research
studies among the Awardees is envisioned.  The NCI Coordinator and all
Awardees funded for research on the same solid tumor will meet
initially to discuss research activities and establish priorities among
the Awardees.  Subsequent periodic meetings will be scheduled to review
progress and coordinate new research activities.  Therefore, each
Awardee should anticipate the need to attend two meetings per year with
the NCI Coordinator and other Awardees in the same solid tumor research
area to coordinate activities.

The Government, via the NCI Coordinator, will have access to data
generated under this cooperative agreement and may periodically review
the data.  However, the awardee will retain custody and primary rights
to the data developed under these awards, and timely publication of
major findings by the Team members is encouraged.  Publication or oral
presentation of work done under this agreement will require appropriate
acknowledgement of NCI support.

ARBITRATION COMMITTEE

An arbitration panel of external consultants will be created as needed
to resolve any irreconcilable differences of opinion between the NCI
coordinator and the Team(s) related to scientific/programmatic matters
or implementation of a proposed operating policy.  The panel will
include one member selected by the Team(s), one member selected by the
NCI, and a third member chosen by the other two members of the
arbitration panel.  The NCI arbitration process for the cooperative
agreement in no way affects the rights of awardees to appeal selected
post award administrative decisions in accordance with PHS regulations
at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis should be placed on the need
for inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 in
Section 2, 1-4 of the Research Plan AND summarized in Section 2, E,
Human Subjects. Applicants/offerors are urged to assess carefully the
feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations
(i.e., Native Americans (including American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded. However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit by May 29, 1992, 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 RFA in response to which the application is
being submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
is helpful in planning for the review of applications.  It allows NCI
staff to estimate the potential review workload and to avoid conflict
of interest in the review.

The letter of intent is to be sent to:

Ms. Diane Bronzert
Program Director, Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663

Applicants who use express mail or a courier service are advised to
follow the carrier's requirements for showing a street address.  The
address for the Executive Plaza North is:

Executive Plaza North, Room 734
6130 Executive Blvd.
Rockville, MD  20852

APPLICATION PROCEDURES

The research grant application form PHS 398, (rev. 9/91) is to be used
in applying for cooperative agreements. These forms are available at
most institutional business offices; from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892,
telephone (301) 496-7441; and from the NCI Program Director named
below.

The general instructions, e.g., for format and budget issues, included
in the application packet must be followed.

Because the Terms of Cooperation discussed above 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 staff involvement.

Teams that are funded for research on the same type of solid tumor
should anticipate the need to attend two meetings per year to share
data and to coordinate activities.  Travel funds for two
representatives from a Team (one basic researcher and one clinician,
one of whom must be the PI) should be included in the budget.  This
budget item will be negotiable depending on whether or not there are at
least two Teams being funded for research on the same type of solid
tumor.

If the applicant has an approved assurance covering the research
(multiple project assurance for human subjects/full assurance of
compliance for animal subjects), the applicant must provide with the
application the certification of institutional review board (IRB)
approval if humans are involved and the verification of the
institutional animal care and use committee (IACUC) approval if animals
are involved.  These reviews and approvals should occur prior to
submission of the applications for award.  If these reviews and
approvals are unavoidably delayed beyond the submission of the
applications, the certifications and verifications must be submitted
prior to the scheduled review of the applications.  Failure to provide
required certifications and verifications within applications prior to
review could result in rejection of the application.  If animals or
humans will be subjects of the research at performance sites other than
the applicant organizations, the applicants must identify, with the
application, the assurance status of each participant.  Failure to
provide this information within an application could result in return
of the application to the applicant.

The RFA label available in the new revision, September, 1991, of
application form PHS 398 must be affixed to the bottom of the face
page.  Failure to use this label could result in delayed processing of
your application such that it may not reach the review committee in
time for review.  In addition, the RFA number and title must be typed
on line 2a of the face page of the application form and the YES box
must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact photocopies, in one package:

DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892

At the time of submission, two additional copies of the application
must also be sent to:

REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by July 10, 1992.  If an application is
received after that date, it will be returned.  The Division of
Research Grants (DRG) 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 DRG will not accept any application that is essentially the same as
one already reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed by the Division of Research
Grants (DRG) for completeness.  Incomplete applications will be
returned to the applicant without further consideration.  Applications
that are judged non-responsive will be returned by the NCI.  An
application judged to be non-responsive to this RFA may be submitted as
an investigator initiated regular research grant (R01) or program
project grant (P01) at the next receipt date.  The application would
require modification in accordance with either the R01 or P01
guidelines.  The new application would not be considered an application
for a Cooperative Agreement, nor would it be considered a response to
an RFA.  Questions concerning the relevance of proposed research to the
RFA may be directed to program staff as described in the INQUIRIES
section.

Applications may be triaged by an NCI peer review group on the basis of
relative competitiveness.  The NCI will withdraw from further
competition those applications judged to be noncompetitive for award
and notify the applicant and institutional business official.  Those
applications judged to be both competitive and responsive will be
further evaluated, using the review criteria stated below, for
scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities, NCI.  The second
level of review will be provided by the National Cancer Advisory Board.

Review Criteria

o  Scientific merit and feasibility of the proposed research.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research.

o  Adequacy of plans for effective collaboration between laboratory,
clinical, and statistical investigators.

o  Qualifications, demonstrated expertise in both the appropriate basic
and clinical sciences, and proposed responsibilities of the Principal
Investigator and key personnel.

o  Demonstration of availability of and access to appropriate patients
receiving defined treatments on phase III clinical trials and/or to
human tissue with the associated pathological data and clinical
follow-up.

o  Scientific plans and timetable for implementing the proposed
research program.

o  Adequacy of the available facilities and data management resources.
Evidence of the competence of the Central Operations Office and
statistical center with regard to the mechanisms for quality control,
study monitoring, data management and reporting, and data analysis.

o  Plans for effective interaction and coordination among cooperating
institutions within the Study Team, with other Teams working on the
same solid tumor, and with the NCI.

o  Adequacy of provisions for the protection of human subjects.

o  Adequacy of the plans for inclusion of females and minorities.

o  Adequacy of the proposed budget and duration in relation to the
proposed research.

AWARD CRITERIA

The anticipated date of award is April 1, 1993.  Special consideration
will be given to studies with colorectal, breast, ovarian, lung, and
prostate tumors.  Each application is expected to be focused on a
specific solid tumor.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope of
this RFA and inquiries about whether or not specific proposed research
would be responsive are strongly encouraged and should be directed to
program staff listed below.  The program staff welcome the opportunity
to clarify any issues or questions from potential applicants.

Direct inquiries regarding programmatic issues to:

Ms. Diane Bronzert
Program Director, Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663

Dr. Sheila E. Taube
Chief, Cancer Diagnosis Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza South, Room 638
Bethesda, MD  20892
Telephone:  (301) 496-1591
FAX:  (301) 402-1037

Direct inquiries regarding fiscal matters to:

Ms. Mable Lam
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 48
FAX:  (301) 496-8601

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No 93.395, Cancer Treatment Research.  Awards are made under the
authorization of the Public Health Service Act, Title IV Sections 301,
410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public
Law 99-158, 42 USC 285a) and administered under PHS grants policies and
Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74.  This program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
.

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