Full Text CA-93-026

MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM

NIH Guide, Volume 22, Number 18, May 7, 1993

RFA:  CA-93-026

P.T. 34, FF

Keywords: 
  Cancer/Carcinogenesis 
  Clinical Trial 
  Disease Prevention+ 
  Community/Outreach Programs 


National Cancer Institute

Letter of Intent Receipt Date:  July 25, 1993
Application Receipt Date:  August 24, 1993

PURPOSE

The Division of Cancer Prevention and Control (DCPC), National Cancer
Institute (NCI), is interested in continuing the established cancer
control effort which involves practicing oncologists who serve large
minority populations in the NCI clinical trials program.  DCPC invites
applications from domestic institutions with greater than 50 percent of
new cancer patients from minority populations for cooperative
agreements in response to this Minority-Based Community Clinical
Oncology Program (Minority-Based CCOP) Request for Applications (RFA).

The NCI clinical trials network provides support for clinical research
in cancer centers, major university centers, and community programs.
The purpose of this program is to utilize as a national resource those
physicians involved in the care of minority cancer patients who are
available for treatment and cancer prevention and control clinical
trials research.  The linkage of minority cancer patients to the
current clinical trials network will facilitate the transfer of new
technology in treatment and cancer prevention and control practices to
minority communities and their physicians.

The Minority-Based CCOP should:  (1) provide support for expanding
clinical research in minority community settings; (2) bring the
advantages of state-of-the-art treatment and cancer prevention and
control research to minority individuals in their own communities; (3)
increase the involvement of primary health care providers and other
specialists in cancer prevention and control studies; (4) establish an
operational base for extending cancer prevention and control, and
reducing cancer incidence, morbidity, and mortality in minority
populations; and (5) examine selected issues in Minority-Based CCOP
performance (e.g., patient recruitment, accrual, eligibility).

This issuance of the Minority-Based CCOP RFA seeks to build on the
strength and demonstrated success of the Minority-Based CCOP over the
past three years by:  (1) continuing the program as a vehicle for
supporting community participation in treatment and cancer prevention
and control clinical trials through research bases (clinical
cooperative groups and cancer centers supported by NCI); (2) expanding
and strengthening the cancer prevention and control research effort;
(3) utilizing the Minority-Based CCOP network for conducting
NCI-assisted cancer prevention and control research; and (4) evaluating
on a continuing basis Minority-Based CCOP performance and its impact in
the community.

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,
Minority-Based Community Clinical Oncology Program, 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 from domestic institutions for
cooperative agreements to continue the Minority-Based CCOP. New
applicants and currently funded programs are eligible as described
below.

Institutions, organizations and/or physician group applicants for the
Minority-Based CCOP must have greater than 50% of new cancer patients
from minority populations AND, as a group, the participating physicians
listed in the application must have greater than 50 percent of new
cancer patients from minority ethnic groups. The following eligibility
requirements then apply.

o  An applicant may be a hospital, a clinic, a group of practicing
physicians, a health maintenance organization (HMO), or a consortium of
hospitals and/or clinics and/or physicians and/or HMOs, that agree to
work together with a Principal Investigator and a single administrative
focus.

o  A university hospital that is the major teaching institution for
that university AND that has greater than 50 percent of new cancer
patients from minority populations is eligible to apply.

o  A military or Veterans Administration hospital may be included in an
application as a nondominant member of a consortium led by a community
institution.  An unfunded nonuniversity clinical trials cooperative
group member is eligible to apply.

o  Funded Cooperative Group Outreach Program (CGOP) participants are
eligible to apply, but should state in the application that CGOP
support will be relinquished if a Minority-Based CCOP award is
received.

o  Funded Minority Satellite Supplement Program (MSSP) participants are
eligible to apply, but should state in the application that MSSP
support will be relinquished if a Minority-Based CCOP award is
received.

Institutions and organizations NOT eligible to apply as a
Minority-Based CCOP are:

o  A comprehensive, consortial, or clinical cancer center holding an
NCI Cancer Center Support (CORE) grant;

o  A university hospital clinical trials cooperative group member
funded by DCT, NCI; and

o  Currently funded Community Clinical Oncology Programs (CCOPs).

MECHANISM OF SUPPORT

Support of this program will be through the Cooperative Agreement
(U10).  The Cooperative Agreement is an assistance mechanism in which
substantial NCI programmatic involvement with the recipient during
performance of the planned activity is anticipated to assist awardees
in the planning, direction, and execution of the proposed project.  The
anticipated amount of the direct cost awards will range from $100,000
to $200,000.

The total project period for applications submitted in response to this
RFA may not exceed three years for new applicants and four years for
applicants currently supported under this program.

FUNDS AVAILABLE

This RFA is a one-time issuance.  It is anticipated that up to $2.7
million in total costs per year will be committed to specifically fund
applications which are submitted in response to this RFA.  It is
anticipated that up to 12 awards will be made.  This level of support
is dependent on the receipt of a sufficient number of applications of
high scientific merit.  The earliest feasible start date for the
initial awards will be June 1, 1994.  NCI program staff will take into
account demographic and geographic distributions of peer-reviewed and
approved Minority-Based CCOPs in the final funding selection process.
Multiple Minority-Based CCOP applicants approved for funding but who
are competing for the same patient population will be considered, but
all may not be awarded unless warranted by the population density.
Although this program is provided for in the financial plans of NCI,
the issuance of awards pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

Awards for research bases affiliated with Minority-Based CCOPs will be
through Cooperative Agreements under the Community Clinical Oncology
Program RFA.

RESEARCH OBJECTIVES

A.  Background

When compared to the general population, African-Americans have an
increased incidence of a number of malignancies and worse overall
survival rates.  Greater involvement in clinical trials research by
Black, Hispanic, Asian-American, American Indian, and other minority
patients is needed if the advances in clinical research are to be
extended to all ethnic groups, and the results of clinical trials
generalizable to the entire population.  In general, there has been
limited participation in clinical trials research by minority cancer
patients.  In the past, institutions and physicians with access to
large minority populations have not been r research, and few minority
cancer patients and their physicians were impacted by research funded
through the clinical trials network.

NCI's clinical trials network has evolved over the past 30 years.  The
major NCI program initiatives supporting this network are the Clinical
Cooperative Group Program, the Cancer Centers Program, the Cooperative
Group Outreach Program, and the Community Clinical Oncology Program
(CCOP).  Treatment and cancer prevention and control clinical trials
research funded through these programs provides patients and their
physicians with access to state-of-the-art cancer care management
opportunities, and provides oncologists with a source of continuing
education on innovations in cancer therapy, diagnostic techniques, and
treatment applications.

One of the major efforts of the NCI has been to design and implement
program interventions to assure that patients treated in their own
communities have access to the same quality of cancer care and the same
technological advances available to patients treated in major centers.
The CCOP, which was first initiated in 1983, has proven to be a
successful model for bringing the benefits of clinical research to
cancer patients in their communities by providing support for community
physicians to enter patients on treatment research protocols.  In
addition to increasing patient accrual to treatment clinical trials,
the CCOP stimulated many communities to organize their cancer
activities and expedited the development of a local-regional cancer
program.  Increased numbers of physicians, hospitals, and other health
care professionals became involved in CCOP, and quality control
standards of the cooperative groups were maintained.  In 1987 the CCOP
expanded the cancer prevention and control effort to include support
for research in prevention, health promotion, smoking cessation,
chemoprevention, treatment applications, continuing care and
rehabilitation.  With the development and implementation of cancer
control research through the clinical trials network, opportunities
exist for the implementation of effective preventive strategies for
reducing cancer incidence, morbidity and mortality.

Broader access to clinical research protocols is needed in order to
develop and implement effective treatment and cancer prevention and
control strategies in minority populations. Areas of research where
minority involvement is especially needed include:  cancer prevention
and control intervention strategies to improve screening and early
detection practices; methodological research on ways to increase the
educational awareness of individuals at risk for cancer and studies of
barriers to prevention and treatment applications.  The Minority-Based
CCOP has become an important part of these efforts.  It links
physicians caring for large numbers of minority patients to the NCI
clinical trials network.

The CCOP model has been an effective mechanism for facilitating the
linkage of investigators and their institutions with the clinical
trials network.  The Minority-Based CCOP was initially approved by the
NCI, Division of Cancer Prevention and Control Board of Scientific
Counselors in January 1989.  Implementation began in the fall of 1990.
By 1992 the program was beginning to succeed in its goal of providing
minority populations access to clinical trials. While components of
each of the current ten programs were accruing patients to clinical
trials prior to funding, the grant and the Minority-Based CCOP
structure has enabled these groups of physicians to double and, in some
cases, triple previous accrual to treatment trials.  In fiscal 1992,
ten Minority-Based CCOP's accrued nearly 500 patients onto treatment
trials and over 400 patients/subjects onto cancer prevention and
control trials.  Greater than 70 percent of Minority-Based CCOP
patients entered on study during that period are from minority
populations.  In a recent study, 14.1 percent of all patients entered
onto NCI sponsored treatment trials were ethnic minorities.  These ten
programs contributed more than 10 percent of all minority accrual to
NCI sponsored cancer treatment trials.  Minority-Based CCOP accrual
will likely increase as the organizational structures solidify.

B.  Goals and Scope

The Minority-Based CCOP initiative is designed to:

o  Bring the advantages of state-of-the-art treatment and cancer
prevention and control research to minority individuals in their own
communities by having practicing physicians and their patients/subjects
participate in NCI-approved treatment and cancer prevention and control
clinical trials;

o  Provide a basis for involving a wider segment of the community in
clinical research by increasing the involvement of primary health care
providers and other specialists (e.g., surgeons, urologists,
gynecologists) with the Minority-Based CCOP investigators in treatment
and cancer control research, thus providing an opportunity for
education and exchange of information;

o  Provide an operational base for extending cancer control, and
reducing cancer incidence, morbidity, and mortality in minority
populations by accelerating the transfer of newly developed cancer
prevention, detection, treatment, and continuing care technology to
widespread community application;

o  Facilitate wider community participation in future treatment and
cancer control research approved by NCI; and

o  Examine selected issues in Minority-Based CCOP performance (e.g.,
patient recruitment, accrual, eligibility) and evaluate its impact in
the community.

The initiative will be developed and supported by DCPC, NCI.
Participating programs will be required to enter patients/subjects onto
NCI-approved cancer treatment and cancer prevention and control
clinical trials through research bases with which the Minority-Based
CCOP is affiliated.  Minority-Based CCOP performance will be evaluated
on a continuing basis by NCI program staff for its impact on community
cancer treatment and control practices.

Research bases approved for CCOP participation will provide clinical
research protocols in cancer treatment and cancer prevention and
control to Minority-Based CCOPs.

Minority-Based CCOP applicants must demonstrate the potential for
accessing appropriate cancer patients/subjects within their communities
for participation in cancer treatment and cancer prevention and control
protocols provided by their research bases.

SPECIAL REQUIREMENTS

A.  Terms and Conditions of Award

Under the Cooperative Agreement, a partnership will exist between the
recipient of the award and NCI, with assistance from NCI in carrying
out the planned activity.  This assistance will include:  clarification
of Minority-Based CCOP requirements; review of accrual to clinical
trials; monitoring of community efforts to increase minority
participation in clinical research; participation in protocol review;
and discussions on the continuing needs of the program for enhancing
Minority-Based CCOP performance.

The following terms and conditions pertaining to the scope and nature
of the interaction between NCI and the investigators will be
incorporated in the Notice of Grant Award.  These terms will be in
addition to the customary programmatic and financial negotiations which
occur in the administration of grants.  The "Terms and Conditions of
Award:  Nature of NCI Staff Involvement" and "Terms and Conditions of
Award:  Responsibilities of Awardees" described in this section are in
addition to, and not in lieu of, otherwise applicable administrative
guidelines; DHHS grant administration regulations 45 CFR 74; other
DHHS, PHS, and NIH grant administration policy statements; and other
NCI administrative terms and conditions of award.

1.  Nature of NCI Staff Involvement

a.  Protocol Review

All research base protocols utilized by the Minority-Based CCOPs must
be reviewed and approved for CCOP use by the Cancer Control Protocol
Review Committee (CCPRC), Division of Cancer Prevention and Control
(DCPC) and/or the Protocol Review Committee (PRC), Division of Cancer
Treatment (DCT), NCI, prior to implementation.

NCI will not provide investigational drugs, permit expenditure of NCI
funds, or allow accrual credit for a protocol that has not been
approved, or that has been closed (except for patients already on
study).

b.  Monitoring

There will be periodic on-site audits of each Minority-Based CCOP by
representatives of its research base(s), NCI, or an NCI-designee, such
as DCT's current Clinical Trials Monitoring Service contractor.  Such
on-site audits may include review of the following:  use of
investigational drugs; compliance with regulations for Institutional
Review Board (IRB) approval and informed consent (compliance with 45
CFR 46); compliance with protocol specifications; quality control and
accuracy of data recording; and completeness of reporting adverse drug
reactions.  Reports of such on-site audits will be reviewed by the
Quality Assurance and Compliance Section (QACS), Regulatory Affairs
Branch (RAB), Cancer Therapy Evaluation Program (CTEP), DCT, and by the
DCPC Program Director.  In addition, NCI program and grants management
staff will review protocol accrual, fiscal and administrative
procedures.

c.  Data Management

The DCPC Program Director will have access to all data generated under
this award and will periodically review the data management procedures
of the Minority-Based CCOPs.  Data must also be available for external
monitoring if required by NCI's agreement with other Federal agencies,
such as the Food and Drug Administration (FDA).

d.  Investigational Drug Management

The Drug Management and Authorization Section, Investigational Drug
Branch (IDB), CTEP, DCT and Chemoprevention Branch (CB), DCPC staff
will advise investigators of specific requirements and changes in
requirements about investigational drug management that the FDA and NCI
may mandate, either directly or through the research bases.

e.  Organizational Changes

Minority-Based CCOPs must obtain prior written approval of the DCPC
Program Director for certain organizational changes. These changes
include the addition/deletion of a participating physician or a health
professional other than a physician (entering patients/subjects in
cancer prevention and control research in the Minority-Based CCOP), an
affiliate, component, or research base.

A change in the Principal Investigator, or in any key personnel
identified on the "Notice of Grant Award," must have the prior written
approval of the NCI Grants Management Specialist, with the advice of
the DCPC Program Director.

f.  Program Review

Annual progress reports must be submitted to DCPC.  A suggested format
developed by the DCPC Program Director for this purpose will be
provided.  The DCPC Program Director will review the progress of each
Minority-Based CCOP through consideration of the Minority-Based CCOP
annual report, program site visits, patient log, and reports from
affiliated research base(s).  This review may include, but not be
limited to, overall accrual credits, number of new cancer patients
available to the participating Minority-Based CCOP physicians and the
percentage of new cancer patients from minority populations placed on
study, eligibility and evaluability of individuals entered on study,
and timeliness and quality of data reporting.  The Minority-Based
CCOP's performance in accruing cancer patients from minority
populations will be assessed.  The inability of a Minority-Based CCOP
to meet the performance requirements set forth in the 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.

g.  Strategy Sessions

The DCPC Program Director or designee will sponsor strategy sessions as
needed to review the status, progress, and evolving needs of the
Minority-Based CCOP.  These meetings may include discussions of overall
Minority-Based CCOP performance, minority cancer patient recruitment
and retention in clinical research trials, barriers to effective
treatment and cancer prevention and control implementation, and
scientific research required to address specific issues in minority
populations.  The DCPC Program Director will also assist the
Minority-Based CCOP investigators in exploring mutual interests in
cancer prevention and control research and in establishing and
prioritizing goals for evolving cancer programs.

h.  Federally Mandated Regulatory Requirements

The DCPC Program Director or designee and DCT staff will review
mechanisms established by each Minority-Based CCOP to meet the
Department of Health and Human Service (DHHS)/Public Health Service
(PHS) regulations for the protection of human subjects and FDA
requirements for the conduct of research using investigational agents.
At a minimum, these include:

o  methods for assuring that each institution at which Minority-Based
CCOP investigators are conducting clinical trials has a current,
approved assurance on file with the Office for Protection from Research
Risks (OPRR); that each protocol is reviewed by the responsible IRB
prior to patient entry; and that each protocol is reviewed annually by
the IRB so long as the protocol is active;

o  methods for assuring or documenting that each patient (or patient's
parent/legal guardian) gives fully informed consent to participation in
a research protocol prior to the initiation of the experimental
intervention;

o  a system for assuring timely reporting of all serious and unexpected
toxicities to the IDB, CTEP, DCT, according to DCT guidelines and/or to
DCPC according to DCPC guidelines; and

o  implementation of DCPC/DCT requirements for storage and accounting
for investigational agents provided under DCPC/DCT sponsorship.

i.  Arbitration Process

The Terms and Conditions of Award require that the DCPC Program
Director make post-award administrative decisions related to program
performance, programmatic decisions on scientific-technical matters,
and funding adjustments.  NCI will establish an arbitration process
when a mutually acceptable agreement cannot be obtained between the
awardee and the DCPC Program Director.  An arbitration panel (with
appropriate expertise) composed of one member of the recipient group,
one NCI nominee, and a third member chosen by the other two will be
formed to review the NCI decision and recommend a course of action to
the Director, DCPC.  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.

2.  Responsibilities of Awardees

a.  Protocols

All research base protocols utilized by Minority-Based CCOPs must have
been reviewed and approved for CCOP use by the CCPRC, DCPC and/or the
PRC, DCT, NCI, prior to implementation.

The Research base is responsible for the development and implementation
of high quality treatment and cancer prevention and control clinical
trials, and for evaluation of the results of such studies.  To be
eligible to receive credit for accrual to a research base protocol, the
Minority-Based CCOP must have an affiliation agreement with the
research base responsible to NCI for that protocol.

b.  Research Base Affiliation(s)

Each Minority-Based CCOP must affiliate with a national multi-specialty
cooperative group (research base) having a spectrum of treatment and
cancer prevention and control clinical trial protocols available.  Each
Minority-Based CCOP may affiliate with up to four additional NCI
approved research bases.  A Minority-Based CCOP cannot affiliate with
more than one national multi-specialty cooperative group.

Note:  A list of currently eligible research bases may be obtained from
the program official listed under INQUIRIES.

If participation in the protocols of one group competes with that of
another group with which the Minority-Based CCOP is affiliated (e.g.,
two adjuvant protocols for the same eligible Stage II node positive
patient), the Minority-Based CCOP must prioritize the protocols in
order to avoid bias in the allocation of patients to competing
protocols.

Initial affiliations should be maintained during the funding cycle.
When circumstances require changes in research base affiliations, prior
written approval from the DCPC Program Director is required.

c.  Accrual

Patient accrual to clinical trials is expected to be reflective of the
new cancer patient distribution of the participating physicians, that
is, greater than 50 percent of new cancer patients from minority
populations.

Each Minority-Based CCOP is required to accrue a minimum of 50 credits*
per year in treatment clinical trials that are approved by the PRC,
DCT, NCI.  The 50 credit minimum requirement may be waived for
applicants whose specialty is pediatrics and who are able to place a
majority of their eligible patients on protocols.)  As one measure of
performance, it is expected that at least 10 percent of all new cancer
patients for whom protocols are available will be placed on study by
Minority-Based CCOP physicians.

Each Minority-Based CCOP is required to accrue to cancer prevention and
control protocols that have been approved by the CCPRC, DCPC.  Cancer
prevention and control research should be intervention-oriented and may
include such areas as cancer prevention, early detection, patient
management, rehabilitation, and continuing care.  Minority-Based CCOPS
are required to accrue a minimum of 30 credits* in the first year of
funding, 40 credits in the second year, and 50 credits in the third and
fourth years.

The Minority-Based CCOP's ability to meet projected accrual goals to
both cancer treatment and cancer prevention and control clinical trials
will also be assessed.

*  Each protocol approved for CCOP use will be assigned a credit value.
Credits will be based on the complexity of the intervention, the amount
of data management required, and the duration of follow-up.  For
example, each patient accrued to an average Phase II or Phase III
protocol will count 1 credit; an NCI-designated high-priority protocol
1.5 credits; and a childhood acute lymphocytic leukemia protocol 2
credits.  Cancer control protocols will be assessed for credit using a
similar approach.  For example, a randomized Phase III chemoprevention
protocol will be assigned a value of 1 credit per subject entered on
cancer control protocols involving administration of questionnaires
receive an average assignment of 0.3 credits/subject.

d.  Quality Control

The Minority-Based CCOP will follow the procedures required by each of
its research bases and the QACS, RAB, CTEP, DCT/DCPC Program Director.

2.e.  Data Management

The Minority-Based CCOP must provide the DCPC Program Director with
access to all data generated under this award for periodic review of
data management  procedures of the Minority-Based CCOP.  Data must also
be available for external monitoring if required by NCI's agreement
with other Federal agencies, such as the FDA and with NCI's agreements
with pharmaceutical companies for the co-development of investigational
agents.  The awardees will retain custody of and primary rights to
their data.

2.f.  Investigational Drug Management

Investigators performing trials under Cooperative Agreements will be
expected, in cooperation with NCI, to comply with all FDA monitoring
and reporting requirements for investigational agents.

2.g.  Organizational Changes

Certain Minority-Based CCOP organizational changes must have the prior
written approval of the DCPC Program Director. These include the
addition/deletion of a participating physician, a health care
professionals other than a physician (who actively enters patients to
cancer prevention and control trials), an affiliate, component, or
research base.

A change in the Principal Investigator, or in any institution or key
personnel identified on the "Notice of Grant Award," must have the
prior written approval of the NCI Grants Management Specialist, with
the advice of the DCPC Program Director.

h.  Radiotherapy Equipment

Radiotherapy equipment must have its calibration verified according to
standards set by the Radiologic Physics Center (RPC) in order for
institutions to participate in protocols requiring radiation therapy,
as required by the affiliated research base(s).

i.  Monitoring

Each Minority-Based CCOP agrees to periodic on-site audits by
representatives of its research base(s), NCI, or an NCI-designee (Refer
to 1.b. above).

j.  Reporting Requirements

Annual progress reports must be submitted to DCPC.  A suggested format
developed by the DCPC Program Director for this purpose will be
provided.  The DCPC Program Director will review the progress of the
Minority-Based CCOP.  The inability of a Minority-Based CCOP to meet
the performance requirements set forth in the 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 (refer to 1.f. above).

k.  Network Participation

Minority-Based CCOPs are part of a national network for conducting
treatment and cancer prevention and control clinical trials.  As such,
each Minority-Based CCOP may be asked to participate in strategy
sessions or workshops and in the continuing evaluation of the
Minority-Based CCOP and its impact in the community.

l.  Patient Log

Each Minority-Based CCOP agrees to maintain a new patient log or
minimal registry to include age, sex, race, primary site of cancer,
stage of disease, and treatment disposition for the potentially
eligible patient pool (patients with a protocol available for site and
stage) seen by the Minority-Based CCOP investigators.

m.  Federally Mandated Regulatory Requirements

Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS
regulations for the protection of human subjects (Refer to 1.h. above).

n.  Publications and Presentations

Timely publication of major findings is encouraged. Publication or oral
presentation of work done under this agreement requires acknowledgement
of NCI support.

STUDY POPULATIONS

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

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must 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 must be included in the form PHS 398 in the
Research Plan 1- 4, AND summarized in 5, Human Subjects.  If the
required information is not contained within the application, the
application will be returned.  Applicants 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).  To address the
informational request, it is recommended that a breakdown by percentage
of the gender and minority composition of the study population be
provided.  This information may be based on the institutional records
and/or prior experience.

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

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but 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.

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 June 25, 1993, 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, the participating
institution(s), and the 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
that it contains is helpful in planning for the review of applications.
It allows NCI staff to estimate the potential review workload and to
avoid possible conflict of interest in the review.

The letter of intent is to be sent to Dr. Otis W. Brawley at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

A.  Preparation of Applications

General instructions for the preparation of the cooperative agreement
application are contained in the grant application form PHS 398 (rev.
9/91).  Responses to the instructions concerning Human Subjects
verification must be provided when the application is initially
submitted.

Because the Terms and Conditions of Award (discussed in the Special
Requirements Section 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 should describe how the
applicant will comply with NCI staff involvement as well as how all the
responsibilities of awardees will be fulfilled.

An application from a currently funded program will be a competitive
continuation and must include a progress report, which at a minimum
consists of:  (1) a summary of prior Minority-Based CCOP
activities/accomplishments, including a clear presentation of yearly
accrual over the funding period; (2) an evaluation of Minority-Based
CCOP performance by affiliated research base(s); and (3) a complete
description of how the applicant has met the special cooperative
agreement terms and conditions of the award.

1.  Each applicant must demonstrate access to a population with greater
than 50 percent of new cancer patients from minority groups.  Data from
hospital registries, admission, discharge, clinic, and billing records
may be utilized to document the minority new cancer patient population
available to the applicant organization AND its physician participants.

2.  Each applicant must delineate its patient catchment area.  A map of
the service area, designating counties or zip codes from which
approximately 80 percent of the patients will be drawn, should be
provided.  A description of other cancer care resources in the
catchment area (i.e., hospitals, clinics, physicians, cancer centers)
that are not part of the application should be included.  A detailed
demographic description, including a distribution of all new cancer
patients (including minorities) available for participation in clinical
research, should be provided.  The applicant must clearly indicate the
percentage of new cancer patients from minority populations available
to institutions (i.e., hospitals) included in the application AND the
percentage of new cancer patients from minority populations seen by the
participating physicians included in the application.

3.  Each applicant must demonstrate the potential and stated commitment
to accrue a minimum of 50 credits per year to treatment clinical trials
(except if waived for applicants whose specialty is pediatrics).
Documentation must include any prior participation in treatment
research clinical trials with a clear presentation of the number of
patients and credits accrued to NCI approved treatment clinical trials.

A list of the NCI-approved treatment protocols in which the applicant
expects to participate and projected accrual to each must be provided.

4.  Each applicant must demonstrate the potential and stated commitment
to accrue a minimum of 30 credits in the first year of funding, 40
credits in the second year, and 50 credits in the third and fourth
years to cancer prevention and control clinical trials.  Documentation
must include any prior participation in cancer prevention and control
research clinical trials with a clear presentation of the number of
patients and credits accrued to NCI-approved cancer prevention and
control clinical trials.

A list of the NCI-approved cancer prevention and control protocols in
which the applicant expects to participate and projected accrual to
each must be provided.

5.  The ability of Minority-Based CCOPs and research bases to
collaborate in cancer prevention and control research must be
demonstrated by each applicant.  Working with affiliated research
bases, the applicant must provide at least two examples of DCPC
approved intervention cancer prevention and control protocols
appropriate for the Minority-Based CCOP's participation, and should
describe their implementation, including specifics on patient/subject
recruitment, compliance and follow-up.

6.  A designated Principal Investigator is required.  An associate
Principal Investigator should also be named to assure continuity in the
event of resignation of the Principal Investigator.  The qualifications
and experience of both, in terms of ability to organize and manage a
community oncology program that includes treatment and cancer
prevention and control research and related activities, must be
described.

7.  Each applicant is expected to have a committed multidisciplinary
professional group appropriate for its expected protocol participation.
This team may include medical oncologists, surgeons, radiation
oncologists, pathologists, oncology nurses, data managers, health
educators, and other disciplines (e.g., gynecology, urology,
pediatrics, internal medicine, family practice) as appropriate.  The
training and experience of participating physicians must be provided,
along with a description of working relationships.  Any experience
working together as a group, particularly in implementing clinical
treatment and cancer prevention and control research and related
activities, should be included.  An organizational chart showing how
the group will function must also be included.

8.  Each applicant must provide the qualifications and experience of
all proposed support personnel as well as a description of the proposed
duties for each position.

9.  Through formal affiliations with a maximum of five CCOP approved
research bases, only one of which can be a national multi-specialty
cooperative group, each applicant must demonstrate access to both
treatment and cancer prevention and control research protocols.
Evidence must be provided that an affiliation has been established with
at least one NCI-funded research base which has the capacity to provide
both clinical treatment and cancer prevention and control protocols.
In addition, affiliations with research bases offering only cancer
prevention and control protocols are appropriate.  The conditions of
affiliation must be provided in the Minority-Based CCOP-research base
affiliation agreement(s).  Initial affiliations should be maintained
during the funding cycle.

Multiple research base affiliations are permitted provided they are not
conflicting.  The affiliation agreements must state specifically how
the problem of competing protocols will be resolved.

To be eligible to receive accrual credit for entry to an NCI- approved
protocol, the Minority-Based CCOP must have an affiliation agreement
with the research base responsible to NCI for that protocol.

Note:  A list of currently eligible Research Bases may be obtained from
the program official listed under INQUIRIES.

11.  Quality control procedures must be described in detail.  Assurance
of quality is the joint responsibility of the Minority-Based CCOP and
its research base(s).  Quality control procedures of the research base
will be applied to the Minority-Based CCOPs and should be specified in
the affiliation agreement between the Minority-Based CCOP and the
research base.

Procedures for investigational drug monitoring and data management must
also be described.

12.  The availability of facilities, including laboratories, inpatient
and outpatient resources, cancer registries, etc., must be described.
A statement of commitment from each participating institution or
organization and/or documentation of consortium arrangements must be
provided.  Evidence of involvement with community-based voluntary
organizations must be provided.  Evidence of involvement with
community-based voluntary organizations may be submitted.  In addition,
each applicant must have a defined space for administrative activities
and administrative personnel that will serve as a focus for data
management, quality control, and communication.

13.  Allocation of funds to support community costs for receipt,
handling, and quality control of patient data must be specified.
Allowable items in the budget are requests for full or part-time
administrative personnel, data managers, and study assistants; supplies
and services directly related to study activities (e.g., processing and
sending material for pathology review, processing and sending port
films for radiation therapy quality control); and appropriate travel to
meetings directly related to study activities (e.g., research base
meetings, NCI-sponsored strategy sessions/workshops, local travel).
Funding is not allowed for clinical care provided to patients (e.g.,
reimbursement of patient care expenses; transportation costs).
Physician compensation is only an allowable cost for the Principal
Investigator (PI) and Co-PI, specifically for time spent on
Minority-Based CCOP organizational/administrative tasks.  Justification
must be provided for personnel time, effort and funds requested.

Special personnel resource needs to support the recruitment and
retention of eligible minority patients on clinical trials may be
requested.

Method of Applying

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 offices of sponsored research; from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301/710-0267; and from the NCI program official listed under INQUIRIES.

A suggested format will be sent to all applicants requesting the RFA or
submitting a letter of intent.  All applicants are encouraged to obtain
and use the suggested format instructions for organizing the specific
information concerning the RFA programmatic requirements in the PHS
398.

The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page.  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 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, clear, and single-sided
photocopies, in one package to:

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:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Rockville, MD  20852

Applications must be received by August 24, 1993.  If an application is
received after that date, it will be returned to the applicant.  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

Upon receipt, applications will be reviewed by DRG staff for
completeness and NCI staff for responsiveness.  Incomplete applications
will be returned to the applicant without further consideration.  If
the application is not responsive to the RFA, NCI staff will return it.

If the number of applications is large compared to the number of awards
to be made, applications may receive a preliminary scientific peer
review (triaged) to determine their relative competitiveness.  The NCI
will withdraw from further competition those applications judged to be
non-competitive for award and notify the applicant Principal
Investigator and institutional official.  Those applications judged to
be competitive will undergo further scientific merit review in
accordance with the criteria stated below for scientific/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  Ability to access through participating Minority-Based CCOP
physicians a population with greater than 50% of new cancer patients
from minorities.

o  Ability to accrue a minimum of 50 credits per year to treatment
clinical trials and a minimum of 30 credits per year to cancer
prevention and control clinical trials in the first year, 40 credits in
the second year, 50 credits in the third and fourth years.  The NCI
Program Director may waive the accrual requirement for applicants whose
specialty is pediatrics.  Each applicant's ability to access the
appropriate populations, professional disciplines, and facilities to
participate with affiliated research bases in at least two DCPC
approved cancer prevention and control intervention protocols will be
appraised.  Any prior participation in treatment and cancer prevention
and control research will be considered.

o  Qualifications and experience of the Principal
Investigator/associate Principal Investigator, in terms of ability to
organize and manage a community oncology program that includes both
treatment and cancer prevention and control research and related
activities.

o  Training, experience, and commitment of participating physicians for
accruing individuals to protocols in which the applicant has agreed to
participate.  The experience of proposed investigators in the entry and
treatment of cancer patients on research trials (gained from residency,
fellowships, postdoctoral training and/or subsequent practice) will be
appraised.  For multidisciplinary studies, evidence of the availability
of appropriate professional resources (e.g., radiotherapy, pediatrics,
surgery, gynecology, urology, pathology, internal medicine, family
practice, nursing, and nutrition) will be required.  Experience or
special skills in cancer prevention and control research and related
activities will be considered, together with availability of other
community resources and personnel for such clinical trials.  Previous
involvement by participating physicians and the applicant organization
in cancer care management, clinical research, and related activities in
minority populations will be assessed.

o  Stability of the functional unit or group applying to become a
Minority-Based CCOP.  Preexisting organizational affiliations of at
least a core of the group applying, and evidence of stable working
relationships, will be appraised. Examples of established consortium
arrangements, and committee structure which demonstrates the
participation of appropriate physicians and administrators, may be
submitted.  Evidence of previous success as a group in implementing
clinical treatment and cancer prevention and control research and
related activities will be considered.

o  Qualifications and experience of all proposed support personnel
relative to their position descriptions.  The relevant credentials and
expected contributions to the program of personnel resources not
fiscally supported by the award will be considered.

o  Adequacy of quality assurance mechanisms for both treatment and
cancer prevention and control interventions, and adequacy of procedures
for investigational drug monitoring and data management.

o  Adequacy of available facilities, including laboratories, in-patient
and outpatient resources, cancer registries, etc., and adequacy of
space for administrative activities and personnel.

o  Appropriateness of research base affiliations and of the treatment
cancer prevention and control research protocols chosen.  Affiliation
agreements must be provided in the application.

o  For competitive continuations, adequacy of progress during the
funding period, including ability to meet the minimum accrual credits
in cancer treatment and cancer prevention and control, progress made as
a Minority-Based CCOP, and evaluation of Minority-Based CCOP
performance by affiliated research bases(s).  Consideration will be
given to previous accrual and the ability to meet the previous accrual
projections for which the CCOP was funded.  The research base
evaluation report(s) must be provided in the application.

The review group will critically examine the submitted budget and will
recommend an appropriate budget and period of support for each
favorably recommended application.

Allowable items in the budget are requests for full or part-time
administrative personnel, data managers, and study assistants; supplies
and services directly related to study activities (e.g., processing and
sending material for pathology review, processing and sending port
films for radiation therapy quality control); and appropriate travel to
meetings directly related to study activities (e.g., research base
meetings, NCI-sponsored strategy sessions/workshops, local travel).
Special personnel resource needs to support the recruitment and
retention of eligible minority patients on clinical trials will be
considered.  Funding is not allowed for clinical care provided to
patients. (e.g., reimbursement of patient care expenses; transportation
costs).  Physician compensation is allowable only for time spent on
Minority-Based CCOP organizational/administrative tasks.  Justification
must be provided for personnel time and effort and funds requested.

AWARD CRITERIA

The anticipated date of award is June 1, 1994.  NCI program staff will
take into account demographic and geographic distribution of applicants
in the final funding selection process to assure inclusion of minority
and underserved populations.  Multiple Minority-Based CCOP applicants
for funding who are competing for the same patient population will be
considered, but all may not be awarded unless warranted by the
population density.

INQUIRIES

Written and telephone inquiries concerning the objectives and
scope of this RFA or inquiries about whether or not specific
proposed research would be responsive are encouraged.  The Program
Director welcomes
the opportunity to clarify any issues or questions from
potential applicants.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Otis W. Brawley, M.D.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 300
Bethesda, MD  20892
Telephone:  (301) 496-8541

Direct inquiries regarding fiscal matters to:

Ms. Crystal Elliott
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 13.399, Cancer Control.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410 as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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