Full Text CA-97-016
 
MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM
 
NIH GUIDE, Volume 26, Number 24, July 25, 1997
 
RFA:  CA-97-016
 
P.T.


Keywords: 

 
NATIONAL CANCER INSTITUTE
 
LETTER OF INTENT RECEIPT DATE: September 23, 1997
 
APPLICATION RECEIPT DATE: November 18, 1997
 
PURPOSE
 
The Division of Cancer Prevention and Control (DCPC), 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), DCPC, invites applications
from domestic institutions with the capability and intent to serve
new cancer patients largely from minority populations for cooperative
agreements in response to this Minority-Based Community Clinical
Oncology Program (Minority-Based CCOP) Request for Applications
(RFA). Applicants for new and currently funded Minority-Based CCOPs
are invited to respond to this 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 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.
 
The 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
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, D.C.  20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic institutions for
cooperative agreements to continue the Minority-Based CCOP.
Institutions, organizations and/or physician group applicants for the
Minority-Based CCOP must have greater than 40 percent of newly
diagnosed cancer patients 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.
 
o 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.
 
o A university hospital that is the major teaching institution for
that university AND which has greater than 40 percent of new cancer
patients from minority populations is eligible.
 
o 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.
 
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 MBCCOP award is received.
 
o An unfunded non-university clinical trials cooperative group member
is eligible.
 
o Funded Minority Satellite Supplement Program (MSSP) participants
are eligible, but the application should include a statement 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 include:
 
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 the Division of Cancer Treatment, Diagnosis, & Centers
(DCTDC), NCI.
 
o Currently funded Community Clinical Oncology Programs (CCOPs).
 
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 for applicants
currently supported under this program.  The anticipated award date
is June 1, 1998.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the sizes of awards will
vary also.  Awards and level of support depend on receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the NCI,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.
 
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 $2.7 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 ten
awards will be made. This level of support is dependent on the
receipt of a sufficient number of applications of high scientific
merit. 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 $100,000 to $250,000.  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 approved Minority-Based CCOPs in
the final funding selection process.  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.
 
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 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 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 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. In
the year ending 1996, there were eight programs in seven states, and
Puerto Rico involving approximately 35 hospitals (9 affiliates and 26
components) and over 300 physicians.
 
Approximately 70 percent of Minority-Based CCOP patients entered on
study during that period are from 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.  GOALS AND SCOPE
 
The Minority-Based CCOP initiative is designed to:
 
o 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/subjects participate in NCI-approved cancer treatment and
prevention and control clinical trials;
 
o 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;
 
o 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;
 
o Facilitate wider community participation among racial/ethnic
minorities, women, and other under served populations in cancer
treatment and prevention and control research approved by NCI;
 
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, early detection, treatment, patient management,
rehabilitation, and continuing care technology to widespread
community application; and
 
o 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/subjects 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 relate directly to NCI 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/subjects within their
communities for participation in cancer treatment and prevention and
control protocols provided by their research bases.
 
SPECIAL REQUIREMENTS
 
In addition to the customary programmatic and financial negotiations
that occur in the administration of grants, 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; they are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines; DHHS grant administration
regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration
policy statements; and other NCI administrative terms of award.
 
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.
 
A.  RESPONSIBILITIES OF MINORITY-BASED CCOP
AWARDEES
 
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, Diagnosis, and Centers (DCTDC), 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 term of award and are available on
request from the Cancer Therapy Evaluation Program (CTEP), DCTDC or
the CORB/DCPC.
 
 1.  Protocols
 
All protocols used by 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,
Diagnosis, and Centers (DCTDC), 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.
 
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 DCPC 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 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 are maintained by
minority patients of 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, DCTDC, 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 a minimum
of 50 credits* per year to cancer prevention and control clinical
trials 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.  New applicants for the
Minority-Based CCOP award 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 continuation 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.  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 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; a 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 subject 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 subject
entered.  Follow-up credit for chemoprevention protocols may also be
awarded.
 
 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 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.
 
 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.
 
 7.  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
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), DCTDC, and by the DCPC 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. These should include the following standards:
 
o 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.
 
o 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.
 
o 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 DCPC.  A suggested
format developed by the DCPC 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/Subject Log
 
Each Minority-Based CCOP will be asked to periodically maintain and
verify a new patient/subject 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/subject 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:
 
o 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;
 
o 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;
 
o a system for assuring timely reporting of all serious and
unexpected toxicities to the Investigational Drug Branch, CTEP,
DCTDC, according to DCTDC guidelines and/or to DCPC according to DCPC
guidelines; and
 
o implementation of DCPC/DCTDC requirements for storage and
accounting for investigational agents provided under DCPC/DCTDC
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.  NATURE OF 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 Control Protocol Review Committee
(CCPRC), Division of Cancer Prevention and Control (DCPC) and/or the
Protocol Review Committee (PRC), DCTDC, 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 DCTDC's current Clinical Trials Monitoring Service
contractor.
 
The DCPC and CTMB/CTEP will review and provide advice regarding
mechanisms established for study monitoring, including the on-site
auditing program. DCPC/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 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).
 
 4.  Investigational Drug Management
 
The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch
(PMB), CTEP, DCTDC and Chemoprevention Investigational Studies Branch
(CISB), Chemoprevention Research Program (CPRP), and DCPC staff 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 DCPC 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/subjects in cancer prevention
and control research in the Minority-Based CCOP, an affiliate,
component, or research base.
 
 6.  Program Review
 
The DCPC Program Director will review the annual progress report
submitted by each Minority-Based CCOP. A suggested format will be
developed by the DCPC Program Director for this purpose.  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, and reports from affiliated research bases.
This review may include, but not be limited to, overall accrual
credits, percent of available patients/subjects 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 DCPC Program Director or designee will sponsor strategy sessions
when indicated, attended by principal investigators from the
Minority-Based CCOPs and appropriate DCPC/DCTDC 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 DCPC/DCTDC
attendees.  The principal investigators will have the primary
responsibility for analyzing and prioritizing the research questions
to be developed into clinical trials. The DCPC 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 DCPC Program Director or designee and DCTDC 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  on programmatic decisions of scientific or 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, 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.
 
STUDY POPULATIONS
 
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 new policy results from
the NIH Revitalization Act of 1993 (Section 492B of  Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which were published in the Federal
Register of March 28, 1994 (59 FR 14508-14513) and reprinted in the
NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18,
1994.
Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by September 23, 1997, 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 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 should be sent to:
 
Lori Minasian, MD, FACP
Acting Chief, Community Oncology & Rehabilitation Br.
Division of Cancer Prevention and Control, NCI
Executive Plaza North, Room 300
6130 EXECUTIVE BLVD, MSC-7340
Bethesda, Maryland 20892-7340
Telephone:  (301) 496-8541
Fax:    (301) 496-8667
E-mail: MinasiaL@dcpcepn.nci.nih.gov
 
APPLICATION PROCEDURES
 
A.  PREPARATION OF APPLICATIONS
 
General instructions for the preparation of the cooperative agreement
application are contained in the research grant application Form,
PHS-398 (rev. 5/95).  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
continuation 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; 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 DCPC's established accrual
goals.
 
2.  A plan for continuing to meet prevention and control accrual
requirements, including plans for follow-up of subjects 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 with
greater than 40 percent of new cancer patients from minority groups
and must include plans for recruiting and maintaining women and
minority participants.  Data from hospital registries, 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.
 
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.  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.
 
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.
 
5.  New applicants must provide 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/subject 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/ subject 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 a maximum of five research
bases, only one of which may be a national multi specialty
cooperative group, 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.
 
METHOD OF APPLYING
 
The research grant application form PHS-398 (Rev. 5/95) must be used
in applying for cooperative agreements. These forms are available at
most institutional business offices; from the Office of Extramural
Research and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, Maryland 20892-7910
(Telephone: 301/435-0714; E-mail: asknih@odrockml.od.nih.gov); and
from the NCI program official named in the LETTER OF INTENT Section.
 
A suggested format will be sent to all applicants requesting an 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 (Rev. 5/95) 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, exact photocopies, in one
package to DRG at the address listed below.  The photocopies must be
clear and single-sided.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
6701 Rockledge Dr., Rm 1040
Bethesda, Maryland
Express Mail: Bethesda, MD 20817
 
At the time of submission, two (2) additional copies of the
application must also be sent to the National Cancer Institute at the
address listed below:
 
Ms. Toby Friedberg
Review Logistics Branch
Division of Extramural Activities
National Cancer Institute
Executive Plaza North - Room 636
6130 Executive Boulevard
Bethesda, Maryland  20892
Express Mail: Rockville, Maryland 20852
 
It is important to send these copies at the same time that the
original and three (3) copies are sent to DRG; 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 November 18, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.  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
 
A.  REVIEW PROCEDURES
 
Upon receipt, applications will be reviewed for completeness by DRG
staff and for responsiveness by NCI staff.  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.
 
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, all
applicants will receive a written critique and may undergo a process
in which only those applications deemed to have the highest
scientific merit 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 with greater than 40 percent of new cancer
patients 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 as appropriate
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 will be funded at a yearly accrual
goal that may be 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 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.
 
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 resources 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 continuations, 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 base(s).  Deliberation 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 subjects 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 provisions for the
protection of human subjects, recruitment plans for the inclusion of
women, minorities and subpopulations to clinical trials, and the
safety of the research environment.
 
AWARD CRITERIA
 
The anticipated date of award is June 1, 1998.  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 under served 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 or telephone inquiries concerning the objectives and scope of
this RFA or inquiries about whether or not specific proposed research
would be responsive are encouraged and should be directed to Dr. Lori
Minasian at the address provided in Letter of Intent.  The Program
Director welcomes the opportunity to clarify any issues or questions
from potential applicants.
 
Direct inquiries regarding fiscal matters to:
 
Ms. Crystal Wolfrey
Grants Administration Branch
Office of the Director, NCI
Executive Plaza South, Room 243
Bethesda, Maryland 20892
Telephone: (301) 496-7800, Ext. 282
Email: WolfreyC@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control. Awards are 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 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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