MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM

Release Date:  March 30, 1999

RFA:  CA-99-009

P.T.

National Cancer Institute

Letter of Intent Receipt Date:  July 22, 1999
Application Receipt Date:  August 27, 1999

PURPOSE

The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), is
continuing the established cancer control effort which involves practicing
oncologists who serve large minority populations in the NCI clinical trials
program.  The Community Oncology and Rehabilitation Branch (CORB), DCP, invites
domestic institutions with the capability and intent to serve new cancer patients
largely from minority populations to apply for cooperative agreements in response
to this Minority-Based Community Clinical Oncology Program (Minority-Based CCOP) 
Request for Applications (RFA).  Currently funded Minority-Based CCOPs are also
invited to respond to this RFA.

The NCI clinical trials program provides a network of support for clinical
research in cancer centers, major university centers, and community programs. 
The purpose of this program is to support 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 also
facilitate the transfer of new technology in treatment and cancer prevention and
control practices to minority communities and their physicians.

This reissuance of Minority-Based CCOP will:  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 Minority-Based CCOP RFA seeks to strengthen the Minority-Based CCOP by: 1)
continuing the program as a vehicle for supporting community participation in
cancer treatment and 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 Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC 20402-
9325 (telephone 202-512-1800), or at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications for cooperative agreements to continue or establish  Minority-Based
CCOPs may be submitted by domestic institutions only. Institutions, organizations
and/or physician group applicants for the Minority-Based CCOP must document that
at least 40 percent of their newly diagnosed cancer patients are from minority
populations.  Other eligibility requirements for new applicants and currently
funded programs are described below.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal Investigators: 
(1) An applicant may be a hospital, clinic, group of practicing physicians,
health maintenance organization (HMO), or 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; (2) A university hospital that
is the major teaching institution for that university AND which has greater than
40 percent of its new cancer patients from minority populations is eligible; (3)
A military treatment facility (MTF) or Veterans Administration hospital may be
included in an application as a nondominant member of a consortium led by a
community institution; (4) 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 MB-CCOP award is received; (5) An unfunded non-
university clinical trials cooperative group member is eligible; (6) Funded
Community Clinical Oncology Program (CCOP) participants are eligible to apply for
competitive renewal, but should state in the application that the current CCOP
support will be relinquished if a MB-CCOP award is received.

Institutions and organizations NOT eligible to apply as a Minority-Based CCOP
include: (1) A comprehensive, consortial, or clinical cancer center holding both
an NCI Cancer Center Support core grant and a clinical trials cooperative group
U10 award funded by the Division;  (2) A university hospital clinical trials
cooperative group member funded by the Division of Cancer Treatment and Diagnosis
(DCTD), NCI; (3) Foreign institutions.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be a
cooperative agreement (U10), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NCI scientific and/or programmatic
involvement with the awardee is anticipated during performance of the activity. 
Under the cooperative agreement, the NCI purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Details of the
responsibilities, relationships and governance of the study to be funded under
cooperative agreement(s) are discussed later in this document under the section
"Terms and Conditions of Award."

The total project period for applications submitted in response to this RFA may
not exceed 3 years for new applicants, and no more than 5 years for applicants
currently supported under this program.  Currently supported applicants will be
funded for 3, 4, or 5 years depending upon priority score/percentile, review
committee recommendations, and programmatic considerations.  The anticipated
award date is June 1, 2000.

NCI has determined that there is a continuing program need for community
participation in cancer clinical research trials, both cancer treatment and
prevention and control.  This RFA will be published in the NIH Guide for Grants
and Contracts periodically, provided funds are available.

FUNDS AVAILABLE

It is anticipated that up to $1.9 million in total costs per year for 3 years
will be committed to specifically fund applications that are submitted in
response to this RFA. It is anticipated that up to seven awards will be made. 
Because the nature and scope of the research proposed in response to this RFA may
vary, award sizes are expected to vary also.  Levels of support also depend on
the number of applications of high scientific merit that are awarded.  Although
this program is provided for in the financial plans of NCI, awards pursuant to
this RFA are contingent upon the availability of funds for this purpose.  The
anticipated amount of the direct cost awards will range from $150,000 to $300,000
per year.  Awards for research bases affiliated with Minority-Based CCOPs will
be made through Cooperative Agreements under the Community Clinical Oncology
Program RFA.

NCI program staff will take into account demographic and geographic distributions
of peer-reviewed and scored Minority-Based CCOPs in the final funding selection
process. Multiple Minority-Based CCOP applicants who are proposing to use the
same patient population will be considered for funding, but all may not be
awarded unless warranted by the population density.

RESEARCH OBJECTIVES

A. BACKGROUND

The NCI clinical trials network has evolved over the past 30 years.  The major
NCI program initiatives supporting this network are the Clinical Trials
Cooperative Group Program, the Cancer Centers 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 prevention and control interventions, diagnostic techniques, and treatment
applications.

One of the major efforts of 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
that are  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  local-regional cancer programs. 
Increased numbers of physicians, hospitals, and other health care professionals
participated in CCOP, accruing patients and meeting the same quality control
standards as other members and affiliates. 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.

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 racial/ethnic minority patients is needed if the
advances in clinical research are to be extended to all groups, and the results
of clinical trials are generalizable to the entire population.  In general, there
has been limited participation in clinical trials research by minority cancer
patients.

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, interventions 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 of cancer.  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 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.  In the year ending
1998, there were seven programs in six states and Puerto Rico involving
approximately 30 hospitals and over 300 physicians.

In the past, approximately 70 percent of Minority-Based CCOP patients entered on
study have been minority populations.  In one study, 14.1 percent of all patients
entered onto NCI sponsored treatment trials were from ethnic minorities.  These
Minority-Based CCOPs contributed more than 10 percent of all minority accrual to
NCI-sponsored cancer treatment trials.

B. OBJECTIVES AND SCOPE

The Minority-Based CCOP initiative is designed to: (1) Bring the advantages of
state-of-the-art cancer treatment and prevention and control research to minority
individuals in their own communities by having practicing physicians and their
patients/participants participate in NCI-approved cancer treatment and prevention
and control clinical trials; (2) Provide a basis for involving a wider segment
of the community in cancer prevention and control research and investigate the
impact of cancer therapy and control advances in community medical practices; (3)
Increase the involvement of primary health care providers and other specialists
(e.g., surgeons, family practitioners, urologists, gynecologists) with the
Minority-Based CCOP investigators in cancer treatment and prevention and control
research, providing an opportunity for education and exchange of information; (4)
Facilitate wider community participation among racial/ethnic minorities, women,
and other underserved populations in cancer treatment and prevention and control
research approved by NCI; (5) 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,
early detection, treatment, patient management, rehabilitation, and continuing
care technology to widespread community application; and (6) Examine selected
issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual,
eligibility, patient behavioral modification) and evaluate its impact in the
community.

Participating community programs (Minority-Based CCOPs) will be required to enter
patients/ participants onto NCI-approved cancer treatment and prevention and
control clinical trials through the research base(s) with which each Minority-
Based CCOP is affiliated.  Minority-Based CCOPs may contact NCI program staff
directly for assistance and participation in selected cancer prevention and
control protocols.  Minority-based CCOP performance will be evaluated on a
continuing basis by the NCI program director.

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

SPECIAL REQUIREMENTS

TERMS AND CONDITIONS OF AWARD

The administrative and funding instrument used for this program is a cooperative
agreement (U10),  and anticipated assistance to awardees from the NCI Program
Staff 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.

Under the cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working jointly with the
award recipient in a partnership role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity. Consistent with this concept,
the dominant role and prime responsibility for the activity resides with the
awardee(s) for the project as a whole, although specific tasks and activities in
carrying out the studies will be shared among the awardees and the NCI Program
Staff.

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 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 described in this section are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines; HHS Grant Administration
Regulations at 45 CFR part 74; other HHS, PHS, and NIH Grant Administration
policy statements; and other NCI administrative terms of award.

A. MINORITY-BASED CCOP AWARDEES RIGHTS AND RESPONSIBILITIES

The awardee's programmatic responsibilities for the conduct of the research
supported by this cooperative agreement are described in the INVESTIGATOR'S
HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents
Sponsored by the Division of Cancer Treatment and Diagnosis (DCTD), National
Cancer Institute and the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL
TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and any subsequent
modifications of this document.  These documents are hereby incorporated by
reference as terms of award and are available on request from the Cancer Therapy
Evaluation Program (CTEP), DCTD or the Community Oncology and Rehabilitation
Branch (DCP), Division of Cancer Prevention (DCP).

1. Protocols

All protocols used by Minority-Based CCOPs must have been reviewed and approved
for MB-CCOP use by the Cancer Prevention and Control Protocol Review Committee
(CPCPRC), Division of Cancer Prevention (DCP) and/or the Protocol Review
Committee (PRC), Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior
to implementation.

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.  The research base is responsible for the
development and implementation of high-quality cancer treatment and control
clinical trials and for evaluation of the results of such studies.

2. Research Base Affiliation(s)

Each Minority-Based CCOP must affiliate with a national multi-specialty
cooperative group (research base) having a spectrum of cancer treatment and
prevention and control clinical trials. A Minority-Based CCOP cannot affiliate
with more than one national multi-specialty cooperative group. Each Minority-
Based CCOP may also affiliate with a maximum of four additional research bases
(exceptions may be granted in conjunction with participation in an NCI sponsored
project).

Note:  A list of currently eligible research bases may be obtained from the
program official listed in the Letter of Intent Section.

If participation in the protocols of one group competes with that of another
group with which the Minority-Based CCOP is affiliated, 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 for
the duration of the funding cycle.  When circumstances require changes in
research base affiliations, prior written approval from the DCP Program Director
is required.

3. 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 40
percent of new cancer patients from minority populations. As one measure of over
all clinical trials performance, it is expected that at least 10 percent of all
new cancer patients for whom protocols are available will be placed on clinical
trials by Minority-Based CCOP physicians.

Each Minority-Based CCOP is required to accrue a minimum of 50 credits* per year
to  treatment clinical trials that have been approved by the PRC, DCTD, NCI.  For
applicants whose specialty is pediatrics, the 50 treatment credit minimum
requirement may be waived for those applicants who are able to place a majority
of their eligible patients on protocols.

Each Minority-Based CCOP is eventually required to accrue the minimum of 50*
credits per year to cancer prevention and control clinical trials that have been
approved by the CPCPRC, DCP.  Cancer prevention and control research should be
intervention-oriented and may include such areas as cancer prevention, early
detection, symptom management, rehabilitation, quality of life, and continuing
care.  New Minority-Based CCOP Awardees are required to accrue a minimum of 30
cancer control credits* in the first year of funding, 40 credits in the second
year, and 50 credits thereafter in cancer prevention and control.

Existing Minority-Based CCOPs undergoing competitive renewal are expected to
accrue a minimum of 50 credits per year in cancer treatment and 50 credits per
year in prevention and control.

The Minority-Based CCOP's ability to meet projected accrual goals to both cancer
treatment and prevention and control clinical trials will also be assessed by the
program directors.  The ability to incrementally accrue and maintain minority
enrollment will be assessed and weighted toward credits gained.  For Minority-
Based CCOPs that have demonstrated an outstanding record of accrual to cancer
prevention and control clinical trials, the 50 credit minimum for treatment may
be waived.

* Each protocol approved for MB-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 treatment protocol will count 1
credit; an NCI-designated high-priority protocol, 1.5 credits; and a childhood
acute lymphocytic leukemia protocol, 2 credits.  Cancer prevention and 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 participant entered. Cancer control protocols involving limited
interventions will receive credit that is commensurate with the amount of data
management effort required, usually an assignment of 0.3 or 0.5 credit per
participant entered.  Follow-up credit for chemoprevention protocols may also be
awarded and is counted toward the 50 credit minimum.

4. Quality Control

The Minority-Based CCOP must establish and follow procedures for the assurance
of data quality and quality control in accordance with research base guidelines
and NCI policies.  The Minority-Based CCOP must follow NCI-approved procedures
developed by the research base for the prevention and/or identification of false
or otherwise unreliable data and for quality assurance of data collected by the
research base.

The Minority-Based CCOP must follow policies developed by the research base and
approved by the NCI for auditing the accuracy of scientific data submitted to
them by the research base participants.

5. Data Management

The Minority-Based CCOP must provide the DCP 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.

6. 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.  Specifically, all Minority-Based CCOP
investigators must have an active NCI investigator number.

7. Organizational Changes

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

8. 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).

9. Monitoring

Each Minority-Based CCOP must agree to periodic on-site audits by representatives
of its research base(s), NCI, or an NCI-designee. 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.

Research Base evaluation reports of such on-site audits will be reviewed by the
Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program
(CTEP), DCTD, and by the DCP Program Director.  In addition, NCI program and
grants management staff will review protocol accrual, fiscal, and administrative
procedures.

All institutions participating or collaborating in the Minority-Based CCOPs on
NCI-supported multi-institutional clinical trials must be in compliance with the
monitoring standards established by the research base.  They should include the
following standards: (1) Medical records submitted in support of NCI multi-
institutional trials must conform to usual standards for the maintenance of
clear, accurate, and unambiguous medical records.  White-outs on medical records
are unacceptable; (2) If it is the usual and customary practice of a department,
laboratory, clinic or office to prepare or issue official reports, then only that
department, laboratory, clinic or office can change the report, and alterations
of the medical record must be initialed and dated by the person making such
alterations.  For clinical progress notes, the change must be dated and initialed
by the person making the change.  Only one line should be placed through the
initial entry, so that both the original entry and the change are legible; (3)
The improper modification of important patient records will result in additional
investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead
to suspension of accrual and funding.

10. Reporting Requirements

Annual progress reports must be submitted to DCP.  A suggested format developed
by the DCP Program Director for this purpose will be provided.  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.

11. Network Participation

Minority-Based CCOPs are part of a national network for conducting cancer
treatment and 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 program and its impact in the community. 
Minority-Based CCOPs may also be asked to share their process and outcome methods
for recruiting and maintaining minority enrollment.

12. Patient/Participant Log

Each Minority-Based CCOP will be asked to periodically maintain and verify a new
patient/participant log or minimal registry to include age, sex, race, ethnicity,
insurance status, risk factors, primary site of cancer, stage of disease, and
disposition for the potentially eligible patient/participant pool seen by the
Minority-Based CCOP investigators.

13. Federally Mandated Regulatory Requirements

Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS regulations
for the protection of human subjects.  At a minimum, these include:  (1) methods
for assuring that each facility at which 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; (2) methods for assuring
or documenting that each patient (or patient's parent/legal guardian) gives fully
informed written consent to participation in a research protocol prior to the
initiation of the experimental intervention; (3) a system for assuring timely
reporting of all serious and unexpected toxicities to the Investigational Drug
Branch, CTEP, DCTD, according to DCTD guidelines and/or to DCP according to DCP
guidelines; and (4) implementation of DCP/DCTD requirements for storage and
accounting for investigational agents provided under DCP/DCTD sponsorship.

14. Publications

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

B. NCI STAFF INVOLVEMENT

1. Protocol Review

All protocols used by the Minority-Based CCOPs must be reviewed and approved for
CCOP use by the Cancer Prevention and Control Protocol Review Committee (CPCPRC),
Division of Cancer Prevention (DCP) and/or the Protocol Review Committee (PRC),
DCTD, 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).

2. 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 DCTD's
current Clinical Trials Monitoring Service contractor.

The DCP and CTMB/CTEP will review and provide advice regarding mechanisms
established for study monitoring, including the on-site auditing program. 
DCP/CTEP and/or its contractor staff may attend the on-site audits conducted by
the research base or its NCI designee as observers.

3. Data Management

The DCP 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).

4. Investigational Drug Management

The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB),
CTEP, DCTD and the Chemoprevention Branch (CB), Cancer Prevention Research
Program (CPRP), DCP will advise investigators of specific requirements and
changes in requirements about investigational drug management that the FDA and
NCI may mandate.

5. Organizational Changes

The DCP Program Director will review requests for certain organizational changes
and provide written approval.  These changes include the addition/deletion of a
participating physician or other health professional entering
patients/participants in cancer prevention and control research in the Minority-
Based CCOP, an affiliate, component, or research base.

6. Program Review

The DCP Program Director will review the annual progress report submitted by each
Minority-Based CCOP.  A suggested format will be developed by the DCP Program
Director for this purpose.  The DCP Program Director will review the progress of
each Minority-Based CCOP through consideration of the Minority-Based CCOP annual
report, program site visits, and reports from affiliated research bases.  This
review may include, but not be limited to, overall accrual credits, percent of
available patients/participants placed on study, eligibility and evaluability of
individuals entered on study, and timeliness and quality of data reporting.  The
inability of a Minority-Based CCOP to meet the performance requirements set forth
in the Terms and Conditions of Award,  or significant changes in the level of
performance, may result in an adjustment of funding, withholding of support,
suspension or termination of the award.

7. Strategy Sessions

The DCP Program Director or designee will sponsor strategy sessions when
indicated, attended by principal investigators from the Minority-Based CCOPs and
appropriate DCP/DCTD staff.  At these meetings, information relevant to the
Minority-Based CCOPs will be reviewed and discussed, including such issues as
overall Minority-Based CCOP performance and the science of current or proposed
clinical trials.  Data will be analyzed and the outstanding research questions
established and prioritized into national research goals by Minority-Based CCOP
investigators and the DCP/DCTD attendees.  The principal investigators will have
the primary responsibility for analyzing and prioritizing the research questions
to be developed into clinical trials.  The DCP Program Director will also assist
the Minority-Based investigators in exploring mutual interests in cancer
prevention and control research.

8. Federally Mandated Regulatory Requirements

The DCP Program Director or designee and DCTD 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.

C. ARBITRATION PROCESS

NCI will establish an arbitration process when a mutually acceptable agreement
cannot be obtained between the awardee and the involved NCI Program Staff related
to program performance and programmatic decisions on scientific technical
matters.  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, DCP.  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 HHS regulations at 45 CFR Part 16.

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.

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 28, 1994
(FR 59 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23,
Number 11, March 18, 1994.

Investigators may also obtain copies of the policy from the program staff or
contact person listed below. 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) application 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:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Note: Applicants need to address the Inclusion of Children in their application. 
This CCOP RFA does not include children because the number of children with
cancer is limited and  because the majority are already accessed by a nationwide
pediatric cancer research network.  This exemption is based on Exclusion 4b of
the NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 22, 1999 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 allows NCI staff to estimate the
potential review workload and to avoid possible conflict of interest in the
review.

The letter of intent should be sent to the program staff listed under INQUIRIES.

APPLICATION PROCEDURES

A. Preparation of Applications

The research grant application form PHS-398 (Rev. 4/98) is to be used in applying
for cooperative agreements.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Research and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, Maryland 20892-7910, Telephone: 301/710-0267; E-mail:
grantsinfo@nih.gov.  For those applicants with internet access, the 398 kit may
be found at https://grants.nih.gov/grants/funding/phs398/forms_toc.html

A suggested format will be sent to all applicants upon request or upon 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.  If tables from the
"Suggestions for Organizing Information for a CCOP Application" are included,
those tables should be part of the body of the application, and not included in
the appendix.  Also, 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 must 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 renewal and
must include a progress report that, at a minimum, consists of the following: 
(1) A summary of prior Minority-Based CCOP activities/accomplishments, including: 
a clear presentation of yearly accrual over the funding period (i.e. accrual
tables from previous annual progress reports), a summary of accrual to all cancer
treatment and a summary of accrual to all cancer prevention and control protocols
by gender and ethnicity; and progress in meeting DCP's established accrual goals. 
(2) A plan for continuing to meet prevention and control accrual requirements,
including plans for follow-up of participants from the large prevention trials
as well as plans for implementation of additional cancer control protocols.  (3)
Tables of the current budget and FTEs with a justification for any request for
additional resources.  (4) An evaluation of Minority-Based CCOP performance by
affiliated research base(s).  (5) A complete description of how the applicant has
met the special cooperative agreement terms and conditions of the award including
staffing patterns that may have significantly contributed to minority involvement
in clinical trials.

Both new and currently funded applicants should address the following:

1. Each applicant must demonstrate access to a population in which at least  40
percent of new cancer patients are from minority groups and must include plans
for recruiting and maintaining women and minority participants.  Data from
hospital registries (analytic cases), admission, discharge, clinic, and billing
records may be used to document the new minority cancer patient population
available to the applicant organization AND its physician participants. In
describing the study population, a breakdown, by percentage of the gender and
minority composition of the study population, should be provided.  This
information may be based on the institutional records and/or prior experience.

2. Each applicant must delineate its catchment area.  A map of the service area
should be provided, designating counties or zip codes from which approximately
80 percent of the patients will be drawn.  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.

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 the projected accrual to each must
be provided.

4. Each new applicant must demonstrate the potential and plans for accrual of a
minimum of 30 credits in the first year of funding, 40 credits in the second
year, and 50 credits in the third year to cancer prevention and control
protocols.  Documentation must include any prior participation in cancer
prevention and control research clinical trials with a clear presentation of the
total number of patients and credits accrued to NCI-approved cancer prevention
and control clinical trials.  A list of the NCI-approved prevention and control
protocols in which the applicant expects to participate and the projected accrual
to each must be provided. A complete listing of NCI-approved cancer prevention
and control clinical trials can be requested from the NCI program staff (i.e.
Chief, Community Oncology and Rehabilitation Branch).

5. New applicants must provide an implementation plan for at least two examples
of NCI-approved intervention cancer prevention and control protocols appropriate
for Minority-Based CCOP participation.  For these two protocols, the applicant
should describe their implementation, including specifics on patient/participant
recruitment, compliance, and follow-up.  These studies must come from research
bases with which they propose to affiliate.

The Minority-Based CCOP applicant must document the ability to access the
appropriate physicians and patient/participant populations and adequate
facilities to participate in the proposed clinical trials.

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  must be described in terms of ability to organize and manage a community
oncology program which includes cancer treatment and prevention and control
research and related activities.

7. Each applicant is expected to have a committed multi disciplinary 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.  Where
appropriate, each applicant should include plans to utilize minority
professionals to assure accrual success.  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 cancer treatment and prevention and control research and
related activities, should be included.  An organizational chart showing how the
group will function must also be included.

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

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 only one multi-specialty cooperative group
and up to four additional research bases, each applicant must demonstrate access
to both cancer treatment and prevention and control research protocols.  Evidence
must be provided that an affiliation has been established with at least one NCI-
funded research base that has the capacity to provide both clinical cancer
treatment and 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.

Note: A list of currently eligible research bases may be obtained from the
program official listed in the Letter of Intent Section.

10. 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.

11. 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 may be submitted. In
addition, each applicant must have a defined space for administrative activities
and administrative personnel which will serve as a focus for data management,
quality control, and communication.

12. 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).  Funding is not allowed for clinical support
personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist).
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.

B. Method of Applying

The RFA label available in the PHS-398 (Rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that it may not
reach the review committee in time for review.  In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and the
YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three (3) signed, photocopies, in one package to:

Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040-MSC 7710
Bethesda, Maryland  20892-7710
(20817-7710 for courier service)

Photocopies must be clear and single-sided.  At the time of submission, two (2)
additional copies of the application must also be sent to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North - Room 636
6130 Executive Boulevard, MSC-7399
Bethesda, Maryland  20892-7399
Rockville, Maryland 20852 (for courier service)

It is important to send these copies at the same time that the original and three
(3) copies are sent to CSR; otherwise, the NCI cannot guarantee that the
applications will be reviewed in competition with other applications received on
or before the designated receipt date.

Applications must be received by August 27, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  The Center
for Scientific Review (CSR) will not accept any application in response to this
announcement that is essentially the same as one currently pending initial
review, unless the applicant withdraws the pending application.  The CSR will not
accept any application that is essentially the same as one already reviewed. 
This does not preclude the submission of substantial revisions of applications
already reviewed, but such an application must follow the guidance in the PHS
Form 398 application instructions for the preparation of revised applications,
including an introduction addressing the previous critique.

REVIEW METHODS

A. REVIEW PROCEDURES

Upon receipt, applications will be reviewed for completeness by CSR staff and for
responsiveness by NCI staff.  Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.

Those applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group convened
by the NCI in accordance with the review criteria stated below.  As part of the
initial merit review, a process will be used by the initial review group in which
applications receive a written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally the top half
of the applications under review, will be discussed, assigned a priority score,
and receive a second level review by the appropriate National Cancer Advisory
Board.

B. REVIEW CRITERIA

1. Ability to access through participating Minority-Based CCOP physicians a
population in which at least 40 percent of new cancer patients are from minority
groups. In describing the study population, it is required that a description of
the gender and minority population served be provided, including an outreach plan
and utilization of minority personnel.  This information may be based on
institutional records and/or prior experience.

2. For new applicants, 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, increasing to 50
credits per year in the third year.  Established Minority-Based CCOPs may be
funded at a yearly accrual goal higher than 50 credits for treatment clinical
trials and 50 credits for cancer prevention and control clinical trials.  These
established Minority-Based CCOPs will be evaluated for their past performance in
meeting these accrual goals.  The minimum treatment accrual requirement may be
waived 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 NCI-approved cancer prevention
and control intervention protocols will be appraised.  Any prior participation
in cancer treatment and prevention and control research will be considered.

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

4. 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 multi disciplinary
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.

5. 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
demonstrate the participation of appropriate physicians and administrators may
be submitted.  Evidence of previous success as a group in implementing clinical
cancer treatment and prevention and control research and related activities will
be considered.

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

7. Adequacy of quality assurance mechanisms for both cancer treatment and
prevention and control interventions, and adequacy of procedures for
investigational drug monitoring and data management identification of false or
otherwise unreliable data.

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

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

10. For competitive renewals, adequacy of progress during the funding period,
including ability to meet the minimum accrual credits in cancer treatment and
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 Minority-Based CCOP was funded.
Minority-Based CCOP evaluation by affiliated research bases must be provided.
Plans for continued accrual and follow-up of participants on protocols will be
evaluated.

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 resources needed 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., patient care
reimbursement, transportation costs).  Funding is not allowed for clinical
support personnel (e.g., pharmacist, physicist, clinical psychologist,
dosimetrist). 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 and effort and funds requested.

The initial review group will also examine: the appropriateness of the proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups and plans for the recruitment and retention of
subjects; the provisions for the protection of human and animal subjects; and the
safety of the research environment.

AWARD CRITERIA

The anticipated date of award is June 1, 2000.  Applications recommended by the
National Cancer Advisory Board will be considered by NCI program staff for award
based upon (a) scientific and technical merit; (b) demographic and geographic
distribution of applicants to assure inclusion of minority and underserved
populations;  and (c) availability of funds.  Multiple Minority-Based CCOP
respondents who are competing for the same patient population will be considered,
but all may not be awarded unless warranted by the population density.

SCHEDULE

Letter of Intent Receipt Date:  July 22, 1999
Application Receipt Date:       August 27, 1999
Review by NCAB Advisory Board:  February 2000
Anticipated Award Date:         June 1, 2000

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential applicants is
welcome.

Direct inquiries regarding programmatic issues to:

Worta McCaskill-Stevens, MD
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 305-D, MSC-7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
FAX:  (301) 496-8667
Email:  wm57h@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda, MD  20892-7399
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 496-0275
Email:  tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext. 282
FAX:  (301) 496-8601
Email:  Crystal.Wolfrey@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.399, Cancer Control.  Awards are made under authorization of  sections 301 and
405 of the Public Health Service Act, as amended (42 USC 241 and 284) and
administered under PHS grant 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.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the nonuse 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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