Full Text CA-96-004
NIH GUIDE, Volume 25, Number 1, January 26, 1996
RFA:  CA-96-004
P.T. 34, FF, II

  Clinical Trial 
  Disease Prevention+ 

National Cancer Institute
Letter of Intent Receipt Date:  February 20,1996
Application Receipt Date:  April 18, 1996
The Early Detection Branch (EDB), Division of Cancer Prevention and
Control (DCPC), National Cancer Institute (NCI) invites
investigator-initiated grant applications (R01s) for research to
develop, implement, and test well-defined, hypothesis-based
interventions to improve the participation of women and minority
groups as subjects in cancer prevention and screening clinical
trials.  The focus will be on Phase III research.  Populations of
research interest are defined in the NIH Guidelines on Inclusion of
Women and Minorities as Subjects in Clinical Research and include
women and U.S. minority racial/ethnic groups (American Indian or
Alaskan Native, Asian or Pacific Islander, Black, and Hispanic) and
their subpopulations (DHHS 1994).  Proposed research should build on
current knowledge and research findings concerning clinical trial
participation and patient recruitment, compliance, and retention and
physician referral factors.
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
(Women & Minority Recruitment: Intervention Testing), is related to
all of the special populations targets.  Potential applicants may
obtain a copy of ~Healthy People 2000" (Full Report: Stock No.
017-001- 00474-0) or ~Healthy People 2000" (Summary Report: Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).
Applications may be submitted by for-profit and non- profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
Support of this program will be through the National Institutes of
Health (NIH) traditional research project grant (RO1). Responsibility
for the planning, direction, and execution of the proposed project
will be solely that of the applicant.  Collaboration of investigators
funded under this RFA is planned, see SPECIAL REQUIREMENTS section
below. The total project period for an application submitted in
response to this RFA may not exceed four years. The anticipated award
date is September 30, 1996.
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of an award will
vary also. This RFA is a one-time solicitation.  Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.
Approximately $1.25 million in total costs per year for four years
will be committed to fund applications submitted in response to this
RFA.  It is anticipated that four to six applications will be funded.
The total project period of these awards may not exceed four years.
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 the NCI, awards
pursuant to this RFA are contingent upon the availability of funds
for this purpose.
The NIH Revitalization Act of 1993 directed NIH to establish
guidelines for the inclusion of women and minorities in clinical
research.  The guidelines were to supersede and strengthen prior
policies regarding the participation of women and minorities as
subjects in clinical research, the manner in which clinical trials
are designed and carried out, and the operation of outreach programs
(DHHS 1994).  The NIH published these guidelines in the Federal
Register on March 28, 1994.
Since a primary aim of medical research is to provide findings that
can be used to develop and revise policies and standards of care, it
is important to know if an intervention under study has a
differential effect upon men or women or members of minority groups.
The NIH guidelines are intended to ensure that all future
NIH-supported research is designed to elicit information on both
genders and diverse minority groups (DHHS 1994).
Although female participation in NCI's clinical trials has exceeded
50 percent for several years, women and minority groups overall are
currently under represented as subjects in many clinical studies (El-
Sadr and Capps 1992, GAO 1990, Larson 1994, Svensson 1989).  This
lack of representation has resulted in significant gaps in knowledge
and has limited the usefulness of results from many studies (GAO
Studies without adequate numbers of women and minorities are unable
to detect potentially important biological or clinical differences
among these groups. This lack of information can lead to
misunderstandings of disease etiology as well as inappropriate public
health policies and treatment guidelines (Mohiuddin and Hilleman
1993, Svensson 1989).
The generalizability of findings to larger populations at risk may
also be compromised in studies without appropriate gender and
minority group representation (Antman et al. 1985, NIH 1994a, Kaluzny
et al. 1993, King et al. 1994, Roberson 1994).  The lack of
generalizability seriously limits the applicability of potentially
relevant results to large segments of the population.
In addition, the ability to gain important new information about
cancer that can benefit all Americans is diminished in studies
without representative study populations.  Some populations, such as
Filipino Americans, experience far more favorable cancer rates than
the majority population (Baquet and Hunter 1995).  Gender and
ethnicity can serve as markers for both high and low risk populations
where environmental and genetic causal relationships may be more
easily observed (Cooper 1993).  By identifying and then analyzing
population differences, important new interventions can be developed
to help reduce cancer rates for the entire U.S. population.
While scientific concerns with under representation are important as
noted above, there are also compelling social and ethical reasons to
include women and minorities in clinical research.  These reasons
have to do with fairness and the potential benefits that individuals
and population groups can obtain through participation in
federally-funded research.
The well-known bioethical principle of justice calls for equal
distribution of social goods and services (Beauchamp and Childress
1989).  Justice is clearly not served when important questions
regarding the health of one gender or minority group are ignored,
when one gender or minority group does not participate in clinical
trials, or when one gender or minority group receives treatment that
has been inadequately tested in that group (IOM 1994).
Within the oncology community, it is generally believed that patients
treated under clinical trial protocols receive the best available
medical care and state-of-the-art treatment (AMA 1991, MacIntyre
1991, Thomas et al. 1994, Wittes 1988).  Advantages to participation
extend beyond the patient to their families and friends who benefit
through shared information and resources.  There is also growing
evidence to suggest that care provided in clinical trials may be more
cost effective than that provided by conventional treatment (AMA
Under the bioethical principle of beneficence, all biomedical
research should be designed to maximize benefit and minimize harm
(McCarthy 1994).  Limited clinical trial participation among women
and minorities can lead to harm through denying these groups critical
information that could alter ineffective or detrimental medical care
(Dresser 1992).  There is an urgent need for information that will
lead to the identification and validation of cancer control
interventions for minority populations (Alexander 1995).  Many of
these populations suffer higher cancer rates than the majority
population. Therefore, it becomes imperative that all groups of
people including women and minorities have equal access to the
advantages that participation in clinical trials brings (NIH 1994a,
Spilker and Cramer 1992, Wermeling and Selwitz 1993).
Need for Proposed Research Program
Differential patterns of cancer rates between population groups and
genders are well documented but not well understood.  For example,
black women experience higher rates of breast cancer at significantly
younger ages that do white women, and black males experience rates
for prostate cancer morbidity and mortality that are two to three
times higher than those of white males (Baquet and Hunter 1995).
Compared to the majority population, Native Americans have an
increased risk for several cancers including cancers of the lung,
cervix, and gallbladder and Hispanic Americans as a group have an
increased risk for cancers of the stomach, esophagus, pancreas, and
cervix (Alexander 1995).  In order to develop effective intervention
strategies for higher risk populations, we must investigate the
underlying causes for differences in observed cancer patterns and
include these populations in research studies.
Because many U.S. minority groups are at a lower socioeconomic status
than the general population, it is often more difficult to conduct
clinical trials with minority subjects (Freeman 1993).  Nonetheless,
the level of participation of minorities and women as subjects in
NCI's treatment trials is currently close to their representation in
populations at risk (Tejeda et al. 1994).  The success is due in part
to two recent NCI programs, the Division of Cancer Prevention and
Control's (DCPC) Minority-Based Clinical Community Oncology Program
(MBCCOP) and the Division of Cancer Treatment's (DCT) Increasing
Minority Accrual to Cooperative Clinical Trials program.  However,
the numbers of women and minority groups participating in NCI's
prevention and screening trials lag behind those enrolled in its
treatment trials.  Therefore, the NCI is eager to find effective
strategies and models to increase their participation in these
The participation of women and minority groups as subjects in
clinical trials is a new area of interest and research.  Very little
research on the topic been published or documented (Chen 1994,
Johnson and Arfken 1992, Roberson 1994).  While a number of barriers
to the participation of these groups in clinical studies have been
identified, good culturally sensitive, hypothesis-driven research on
interventions is greatly needed (Bateman et al. 1993, Fleetwood 1993,
Millon- Underwood et al. 1993, NCI 1993, ORWH 1994, Thomas et al.
The selection characteristics, recruitment, and enrollment of
subjects into clinical trials involves multiple factors related to
patients, physicians, and trial protocols.  In many trials only a
small fraction of eligible participants actually enroll.
Investigations into reasons for this lack of enrollment have found
that physician preferences are responsible for the nonentry of a
large proportion of eligible patients (Begg et al. 1983, Hunter et
al. 1987, Taylor et al. 1984).  Efforts to significantly increase the
enrollment of women and minority groups in clinical trials may need
to address physician attitudes regarding clinical trials and
treatment preferences.
Cancer prevention and screening clinical trials differ significantly
from treatment trials (McCabe et al. 1994).  Unlike treatment trials,
they focus on cancer free populations and require the participation
of very large numbers of subjects for very long periods of time.
Therefore, the nature of the accrual process differs and special
strategies are required (Kaluzny et al. 1993).
Incentives for people to participate in cancer prevention and
screening trials differ from cancer treatment trials.  For example,
perceived risk is an especially important issue (ORWH 1994).  People
with cancer are often motivated to participate in trials by strong
feelings of hope.  However, when people feel that they are at low
risk for contracting a disease, there is less motivation to
participate in clinical trials.  In prevention and screening trials,
the research community is asking essentially healthy people to
participate for an uncertain, far off reward (Cassileth et al. 1982).
Given that a significant proportion of many minority groups carry a
heavy burden of poverty, worries about daily safety and well-being
are likely to take precedence over concerns for a disease they do not
yet have (Lacey 1993).
Studies which do not accrue and retain sufficient numbers of eligible
populations at a specified rate risk losses of statistical power and
validity (Taylor et al. 1984).  Prolonged trials suffer from
diminished enthusiasm and risk funding lapses and changes in
important background variables (MacIntyre 1991).  The scientific
"window of opportunity" is small for a study to activate, reach its
targeted accrual, and then close.  If a study languishes due to poor
accrual and lack of adequate gender and minority group
representation, the study question runs a risk of becoming obsolete.
This in turn is a disservice to the people who have chosen to
participate in the trial.
To be able to properly give informed consent, a participant must: 1)
be able to understand the research question being studied, the
methodology employed, and the potential benefits and harm from trial
participation, 2) have an information base sufficient to critically
read and understand an informed consent document, and 3) have the
ability to allow for personal risk (Allen 1994, Henderson 1994). In
our effort to include minorities and women in clinical research, the
medical community must recognize that some people within these groups
may be vulnerable or less advantaged and need special recruitment
consideration and safeguards (NIH 1994b, Spilker and Cramer 1992).
Levine describes vulnerable populations as those people who have
insufficient "...resources, strength, or other needed attributes to
protect their own interests through negotiations for informed
consent" (Levine 1986).  Because women and members of minority groups
may experience discriminatory societal customs, a high proportion of
them may be vulnerable due to such things as poverty, poor health,
and low educational attainment or feel vulnerable due to cultural and
historical factors.  They may, therefore, be in a disadvantaged,
less-powerful position when interacting with the health care system.
Nonetheless, it is not appropriate to treat all women or an entire
minority group as if they were vulnerable.  As Levine notes, this
sort of treatment, "among other things, ...adds unnecessarily to the
burden of stereotypes already borne by such groups"  (Levine 1986).
With implementation of the new NIH guidelines, researchers need to
work closely with their communities, Institutional Review Boards
(IRBs), and ethics committees to enhance accrual rates of target
populations and, at the same time, protect subjects from coercive
practices.  Special staff training and subject recruitment guidelines
may need to be developed to ensure that all potential subjects are
able to fully understand the research project and freely choose (or
decline) to participate.
All clinical interventions and studies involve personal,
culturally-based interactions between patients and staff.  These
human interactions involve values and needs as well as differences
between cultures; the culture of the medical profession, the culture
of "being a patient," and the ethnic cultures of individuals (Morrow
and Bellg 1994).  As with clinical practice, researchers who don't
take these factors into account when designing and implementing
clinical trials with women and minority groups risk problems with
subject compliance and poor study retention.
Research Objectives and Scope
Goal:   To identify interventions that enhance the participation of
under represented populations as subjects in cancer prevention and
screening clinical trials.
Major Objectives:
1.  To develop, implement, and test interventions for target subject
populations that will increase their:
(a)  recruitment,
(b)  compliance,
(c)  retention, and
(d)  referral from physicians and other health care providers
2.  To evaluate the effectiveness and costs of proposed
3.  To disseminate program results to the cancer research community.
Multidisciplinary research teams are encouraged to submit RO1
applications that address research issues within well-defined study
populations such as but not limited to the following:
(1)   Determining optimum ways to recruit subjects. Examining the
effects of communication strategies (e.g., channels, spokespersons,
materials); community outreach strategies; referring health care
provider factors; sponsoring or collaborating organizations; advocacy
groups; peer group support; protocol characteristics; incentives;
psychological factors (e.g., concepts of disease, trust in the
medical system) and counseling of potential subjects on trial
(2)  Determining factors that influence a health care professional's
decision to refer patients to clinical trials.  Examining logistical
and attitudinal barriers and incentive strategies.
(3)  Determining optimum environment-related strategies for clinical
trial recruitment activities (e.g., on-going Wellness clinics, health
fairs, worksites) where information on clinical trials may be
provided as part of a spectrum of other endeavors.
(4)  Determining effective ways to reduce barriers to subject
participation and enhance those factors that help motivate and
facilitate participation.
(5)  Determining optimum ways to assure subject compliance with
clinical trial protocols.  Examining the effect of social support
systems, case management, staff composition and characteristics, and
incentive and reimbursement strategies on compliance and
(6)  Determining optimum ways to retain subjects throughout the
duration of a clinical trial. Examining the effect of communication
patterns between researchers and subjects (e.g., physician support
and encouragement, newsletters), patient education, quality of life,
service and protocol characteristics of the trial, and incentive and
reimbursement strategies on retention.
(7)  Defining issues that should be addressed in the recruitment and
informed consent process for subjects and their health care
providers.  Measuring differential response to the informed consent
(8)  Defining the impact of participation in clinical trials on the
subsequent behavior of subjects and their interactions with health
(9)  Identifying optimal referral sources and networks for potential
clinical trial subjects.
(10)  Examining the role of economic barriers to subject
participation in clinical trials including issues surrounding
reimbursement of patient care costs.
(11)  Examining the role of partnerships between research
institutions and communities on the participation of subjects and
health care providers in clinical trials.  Examining any differences
in support systems used by various populations.
(12)  Examining ways to ensure the protection of "vulnerable"
populations from research abuse (e.g., avoiding coercion or undue
influence to participate or remain in a study).
Applications should propose developing and testing interventions.  An
experimental design is the preferred approach.  Applicants are
encouraged to test and compare multiple innovative strategies and to
assess their relative effectiveness.  Applicants should address cost
issues and include measures of cost effectiveness and efficiency in
their proposals.
In developing research designs and interventions, it is important
that investigators clearly identify their hypotheses and define the
target population(s). Investigators will be required to document that
they have experience working with the target population(s).
Investigators may adapt and test existing participation strategies
used with the general population for use with women and minority
populations.  They may also develop and test new strategies including
those that build upon or extend current NCI programs and resources
such as the Cancer Centers program, the CCOPs, the Leadership
Initiatives, the Patient Education Program, the Physician Data Query
(PDQ) system, and the Cancer Information System (CIS).
All research funded through this RFA must be undertaken within the
context of an ongoing cancer prevention or screening clinical trial.
Written approval in the form of a letter from the Trial's Principal
Investigator must be submitted with the application.  The letter must
state that the application and research plan were reviewed and
approved.  If this document does not accompany the application, the
application will be deemed nonresponsive.  In addition, written
approval of the proposed project by the agency funding the clinical
trial must be received by the NCI prior to issuance of an award.
This RFA is not intended to support or supplement new clinical
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
provisions that are substantially different from the 1990 policies.
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 to 14513) and
reprinted in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
Prospective applicants are asked to submit by February 20, 1996 a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone and FAX numbers 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 may be submitted.  Although a
letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it
contains allows NCI staff to estimate the potential review workload
and avoid conflict of interest in the review.
The letter of intent is to be sent to:
Nancy K. Simpson, Sc.M.
Early Detection Branch
National Cancer Institute
Executive Plaza North, Room 305
6130 Executive Boulevard, MSC 7342
Bethesda, MD  20892-7342
Rockville, MD  20894 (courier express)
Telephone:  (301) 496-3893
FAX:  (301) 496-8667
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301/710-0267, email: girg@drgpo.drg.nih.gov; and from the
NCI Information Office listed under INQUIRIES.
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 signed, photocopies, in one package to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20817 (courier service)
At the time of submission, two additional copies of the application
must be sent to:
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Suite 636
6130 Executive Boulevard - MSC 7405
Bethesda, MD 20892-7405 (U.S. postal service)
Rockville, MD 20852 (courier express)
Applications must be received by April 18, 1996.  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 RFA 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.
Upon receipt, applications will be reviewed for completeness by the
DRG and for responsiveness by the NCI.  Incomplete applications will
be returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NIH staff may contact the
applicant to determine whether it should be returned or submitted for
review in competition with unsolicited applications at the next
review cycle.  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.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with NIH peer review procedures.
As part of the initial merit review, all applications will receive a
written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
National Cancer Advisory Board.
As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.
Review Criteria
o   Applications will be judged on evidence of an in- depth
understanding of the target population; the ability to access and
obtain the participation of target population members; and the
innovativeness of proposed strategies.
o   Scientific, technical, or medical significance and originality of
proposed research;
o   Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
o   Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
o   Availability of the resources necessary to perform the research;
o   Appropriateness of the proposed budget and duration in relation
to the proposed research;
The initial review group will also examine the adherence to special
requirements, and the provisions for the protection of human and
animal subjects, the safety of the research environment, and
conformance with the NIH Guidelines for the Inclusion of Women and
Minorities as Subjects in Clinical Research.
The anticipated date of award is September 30, 1996. Applicants will
compete for funding based on the quality and merit of the proposed
research as determined by peer review, availability of funds, and
programmatic priorities. It is the intent of this program to fund a
portfolio of research projects that will test a variety of strategies
and target a variety of population groups.  Therefore, the extent of
diversity of interventions as well as geographic and racial/ethnic
variation will be considered in making funding decisions.
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
Nancy K. Simpson, Sc.M.
Early Detection Branch
National Cancer Institute
Executive Plaza North, Room 305
6130 Executive Boulevard MSC 7342
Bethesda, MD  20892-7342
Rockville, MD  20894 (courier service)
Telephone:  (301) 496-3893
FAX:  (301) 496-8667
Direct inquiries regarding fiscal issues to:
Robert Hawkins
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard, MSC 7150
Bethesda, MD  20892-7150
Rockville, MD  20852 (courier express)
Telephone:  (301) 496-7800 Ext. 213
FAX:  (301) 496-8601
This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control Science Program.  Awards are
made under the authorization of the Public Health Service Act, Title
IV, Part A. (Public Law 78-410, as amended by Public Law 99-158, 42
USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR part 52 and 45 CFR part 74 and 92.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
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