Full Text PA-96-040
NIH GUIDE, Volume 25, Number 12, April 19, 1996
PA NUMBER:  PA-96-040
P.T. 34

  Clinical Trial 
  Treatment, Medical+ 

National Cancer Institute
The Division of Cancer Treatment Diagnosis and Centers (DCTDC) of the
National Cancer Institute (NCI) invites research grant applications
from interested investigators to conduct innovative therapeutic
clinical trials or new correlative laboratory studies using patient
specimens from therapeutic clinical studies.
The exploratory/developmental (R21) grant mechanism is utilized for
pilot projects or feasibility studies to support creative, novel,
high risk/high payoff research that may produce innovative advances
in science.  The objective of this Program Announcement (PA) is to
encourage applications from individuals who are interested in testing
novel or conceptually creative ideas that are scientifically sound
and may advance progress in human health.  This PA supersedes PA-94-
050, Exploratory Grants to Stimulate Correlative Laboratory Studies
and Innovative Clinical Trials, which was published in the NIH Guide
for Grants and Contracts, Vol. 23, No. 11, March 18, 1994.  The
exploratory grant program provides limited funds (maximum of $100,000
direct costs per year not including indirect costs of any
collaborating institutions) for short-term (up to two years) research
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 PA,
Exploratory Grants for Correlative Laboratory Studies and Clinical
Trials, 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).
Applications may be submitted by foreign and domestic, 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.
Applications may be from a single institution or may include
arrangements with one or more institutions (e.g., consortia, clinical
trials cooperative group) if appropriate.  Applications from minority
individuals, women, and new investigators are encouraged.
Support of this program will be through the National Institutes of
Health (NIH) exploratory/developmental grant (R21) mechanism.
Applicants will be responsible for the planning, direction, and
execution of the proposed project.  All PHS and NIH grants policies
will apply to applications received and awards made in response to
this program announcement.  Applicants may request up to $100,000 per
year in direct costs, not including indirect costs for collaborating
institutions, if any.  The total project period for applications
submitted in response to this PA may not exceed two years.  These
grants are non-renewable and continuation of projects developed under
this program will be through the traditional unsolicited investigator
initiated grant program.
The NCI supports an extensive network of clinical and laboratory
research studies related to cancer therapy through grants and
cooperative agreements.  At present, there is no mechanism targeted
to stimulate the communication of promising and potentially relevant
innovative developments between the laboratory and the clinical
setting.  It has been difficult for investigators to obtain
complementary funding through either the traditional basic research
project grant (R01) mechanism or through the cooperative agreement
(U10) mechanism for either: (1) innovative clinical trials that take
advantage of new developments in the laboratory or (2) novel
correlative laboratory studies to existing clinical trials.  The
small grants (R03) mechanism partially addressed these problems but
the limited funds ($50,000 direct cost cap) prevented larger
innovative clinical studies from being pursued.  These clinical
studies would not be developed fully enough for a standard R01 and
would therefore be considered high risk.  It is expected that these
R21 grants will serve as a basis for planning future clinical
research project grant applications (R01) or NCI cooperative clinical
trial group studies.
Because the exploratory grant mechanism is designed to support
innovative ideas, preliminary data as evidence of feasibility are not
required.  However, the applicant does have the responsibility for
developing a sound research plan.  Originality of the approach and
potential significance of the proposed research are major
considerations in the evaluation.
Research Goals and Scope
The major goal of this initiative is to promote translational and
clinical research through the support of two types of studies: (1)
new therapeutic clinical trials or (2) new correlative studies
relevant to therapeutic clinical trials.  Applications should be
focused on integrating clinical goals with laboratory research areas.
This PA envisions funding new therapeutic clinical trials that move
new treatment strategies more rapidly from the laboratory into the
clinic.  These clinical studies must involve human subjects, be
designed to ultimately improve cancer treatment, and be based on a
strong rationale.  Furthermore, the underlying hypothesis should be
supported by preclinical data.  The proposed clinical protocol should
be included in the Appendix of the application.
This PA has a second research goal of funding new correlative
laboratory studies that are relevant to therapeutic clinical trials.
The clinical correlates must have a future clinical application such
as development of new treatment strategies or identification of
patient subsets for specific treatment therapies.  Examples of
correlative studies include, but are not limited to, analysis of
prognostic markers, cytogenetic studies, pharmacokinetic studies,
studies of drug resistance, and analyses of immune response.  The
laboratory assays must utilize patient specimens from ongoing
clinical trials or specimen banks.  Where applicable, evidence of
statistical support should be included to ensure proper correlation
of assay parameters with clinical outcome.
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 4928 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 14508-14513) 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.
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/710-0267, email:  ASKNIH@odrockm1.od.nih.gov. The title and
number of the program announcement must be typed in line 2 on the
face page of the application and the YES box must be marked.
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or Principal Investigator must be included with
the application.
The completed original application and five legible copies must be
sent or delivered to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD 20817 (for express/courier service)
Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications will be reviewed
for scientific and technical merit by an appropriate peer review
group convened by NIH, in accordance with the standard NIH peer
review procedures.  The second level of review will be provided by a
National Advisory Council or Board.
Review criteria that will be used to assess the scientific merit of
an application are:
o  Scientific merit and originality of the proposed research
o  Potential significance of the proposed research
o  Soundness of the experimental design
o  Qualifications, relevant experience, and commitment of the
o  Availability of the resources necessary to perform the research
o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research
The review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
approved application.
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
o  Quality of the proposed research as determined by peer review
o  Program balance among research areas
o  Responsiveness to the goals and objectives of the PA
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Ms. Diane Bronzert or Dr. Roy S. Wu
Division of Cancer Treatment Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 734
6130 Executive Boulevard MSC 7432
Bethesda, MD  20892-7432
Telephone:  (301) 496-8866
FAX:  (301) 480-4663
Direct inquiries regarding fiscal matters to:
Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800, ext. 256
FAX:  (301) 496-8601
This program is described in the Catalog of Federal Domestic
Assistance No 93.395, Cancer Treatment Research.  Awards are made
under the authorization of the Public Health Service Act, Title IV,
Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241
and 285) and administered under HHS grants policies. 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 routing 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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