EXPLORATORY GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES ANDINNOVATIVE CLINICAL TRIALS



NIH GUIDE, Volume 23, Number 11, March 18, 1994



PA NUMBER:  PA-94-050



P.T. 34



Keywords:

  Cancer/Carcinogenesis 

  Clinical Trial 

  Chemotherapy 



National Cancer Institute



Application Receipt Dates:  June 1, October 1, and February 1



PURPOSE



The Division of Cancer Treatment (DCT) of the National Cancer

Institute (NCI) invites research grant applications from interested

investigators for tightly focused innovative laboratory studies that

are related to clinical trials and/or for innovative clinical trials

that take advantage of new developments in the laboratory.



The exploratory/developmental 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 the PA,

Exploratory/Developmental Grants in Cancer Therapy (PA-92-66), that

was published in the NIH Guide for Grants and Contracts, Vol. 21, No.

13, April 3, 1992.  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 projects.



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 PA,

Exploratory Grants To Stimulate Correlative Laboratory Studies and

Innovative 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 "Healthy People

2000" (Summary Report:  Stock No. 017-001-00473-1) through the

Superintendent of Documents, Government Printing Office, Washington,

DC 20402-9325 (telephone 202/783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted 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.



MECHANISM OF SUPPORT



Support of the 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 the present 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 grant

program.



RESEARCH OBJECTIVES



Background



The NCI supports an extensive network of clinical and laboratory

research studies related to cancer therapy through contracts, 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 that may lead to improved treatment results and

clinical outcomes.  To accomplish this goal, two types of studies

will be supported: (1) the development of new therapeutic clinical

trials or (2) new correlative studies relevant to 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 therapeutic correlates must have a future clinical application

such as development of new treatment strategies or identification of

patient subsets for specific treatment therapies.  This PA does not

support research investigations on diagnostic markers or clinical

correlates which will have no impact on the clinical treatment of

patients.  The laboratory assays must utilize patient specimens from

clinical trials.  Where applicable, evidence of statistical support

should be included to ensure proper correlation of assay parameters

with clinical outcome.



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

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 9, 1994 (FR 59 11146-11151) 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.



(NOTE:  When the proposed study or studies in the RFA or PA involves

a gender specific study or a single or limited number of minority

population groups, this should also be stated to inform potential

applicants and reviewers.)



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91) and will be accepted at the standard application

deadlines as indicated in the application kit.  Application kits are

available at most institutional offices of sponsored research and may

be obtained from the Office of Grants Information, Division of

Research Grants, National Institutes of Health, Westwood Building,

Room 449, Bethesda, MD 20892, telephone 301/710-0267.  The title and

number of the announcement must be typed in line 2a on the face page

of the application.



The completed original application and five legible copies must be

sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



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.



REVIEW CONSIDERATIONS



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  Importance, timeliness and clinical merit of the proposed clinical

trials

o  Relevance of the proposed laboratory studies to the clinical

trials

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

investigator(s)

o  Resources and environment



The review group will critically examine the submitted budget and

will recommend an appropriate budget and period of support for each

approved application.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions:



o  Quality of the proposed research as determined by peer review

o  Availability of funds

o  Program balance among research areas



INQUIRIES



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:



Dr. Roy S. Wu or Ms. Diane Bronzert

Division of Cancer Treatment

National Cancer Institute

Executive Plaza North, Room 734

Bethesda, MD  20892

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

Bethesda, MD  20892

Telephone:  (301) 496-7800, ext. 256

FAX:  (301) 496-8601



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance Nos. 93.393, 93.394, 93.395, 93.396, and 93.399.  Awards

are made under authorization of the Public Health Service Act, Title

IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42

USC 241 and 285) and administered under PHS grants policies and

Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This program is

not subject to the intergovernmental review requirements of Executive

Order 12372 or Health Systems Agency review.



.

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