SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES

NIH GUIDE, Volume 23, Number 10, March 11, 1994



PAR NUMBER:  PAR-94-048



P.T. 34



Keywords:

  Chemotherapy 

  Radiotherapy 

  Surgery 



National Cancer Institute



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



PURPOSE



The Division of Cancer Treatment (DCT), National Cancer Institute

(NCI) announces a program to encourage the submission of small grant

applications for new pilot, phase I, or phase II therapeutic clinical

trials of malignancies that take advantage of recent laboratory

developments.  New and experienced investigators in relevant fields

and disciplines (clinical, surgical, and radiation oncology) may

apply for small grants to test new treatment strategies or do pilot

studies.



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,

Small Grants for Therapeutic 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 or local

governments, and eligible agencies of the Federal government.

Applications may be from a single institution or several institutions

(collaborating institutions, consortia, clinical trials cooperative

groups), if appropriate.  New and experienced investigators are

encouraged to apply.  Applications from minority and women

individuals encouraged.



MECHANISM OF SUPPORT



Support of the program will be through the National Institutes of

Health (NIH) small grants (R03) mechanism.  The small grants research

program provides limited funds (maximum of $50,000 direct costs per

year) for short-term (up to two years) research projects.  These

grants are non-renewable and continuation of projects developed under

this program will be through the regular grant program.



Applicants will be responsible for the planning, direction, and

execution of the proposed project.  Applications submitted in

response to this Program Announcement (PA) will compete for funds

with all other R03 grant applications assigned to the NCI.  The award

of grants in response to this PA is also contingent upon the

availability of funds.  Awards will be administered under PHS grants

policy as stated in the Public Health Service Grants Policy

Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1,

1990.



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 new developments between the laboratory and the clinical

setting.  There is a need for a mechanism to fund short-term studies

and obtain preliminary clinical data rapidly.  It is expected that

these R03 grants will serve as a basis for planning future clinical

research grant applications (R01) or NCI cooperative clinical trial

group studies.



The small grants (R03) mechanism provides research support

specifically limited in time and amount for studies in categorical

program areas (see Research Goals and Scope).  Small grants provide

flexibility for initiating preliminary, short-term studies and are

non-renewable.  Furthermore, the time interval from application to

funding is shortened under the R03 mechanism, thus allowing new ideas

to be investigated or pursued in a more expeditious manner.  The

Cancer Therapy Evaluation Program, DCT, NCI has targeted the use of

the small grants mechanism to support single or several institutions

to perform therapeutic clinical trials to test new ideas.  Support is

needed to encourage new as well as experienced investigators to apply

new treatment approaches.



Research Goals and Scope



The aim of this initiative is to support pilot, phase I, or phase II

therapeutic clinical trials of malignancies to move new treatment

strategies more rapidly from the laboratory into the clinic.

Clinical studies must involve human subjects and be therapeutic in

design.  The clinical studies must be based on a strong rationale and

preclinical data should support the underlying hypotheses.  The

research plan should be focused on the clinical trial proposed.  New

clinical therapeutic trials employing drugs, biologics, radiation, or

surgery whether used as a single agent/modality or in combination are

appropriate.



Laboratory studies may also be proposed to conduct pharmacokinetic,

pharmacodynamic, and other important correlative studies in the

cancer patients receiving therapy.  The laboratory studies should be

in support of the clinical trial, such that their conduct leads to a

greater understanding of the relationship between drug administration

and biological changes in patients.



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.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDIES



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements will be required to include minorities and

women in study populations so that research findings can be of

benefit to all persons at risk of the disease, disorder or condition

under study; special emphasis should be placed on the need for

inclusion of minorities and women in studies of diseases, disorders

and conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale should be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information should be included in the form PHS 398

in Sections 1-4 of the Research Plan AND summarized in Section 5,

Human Subjects.  Applicants are urged to assess carefully the

feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all research projects to include representation of

the full array of United States racial/ethnic minority populations

(i.e., Native Americans (including American Indians or Alaskan

Natives), Asian/Pacific Islanders, Blacks, Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign consortium participants, the policy on inclusion of women

applies fully; since the definition of minority differs in other

countries, the applicant must discuss the relevance of research

involving foreign population groups to the United States'

populations, including minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these

policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91).  Applications must be received by the following

receipt dates:  June 1, October 1, and February 1 of 1994 and 1995.

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 this Program Announcement must

be typed in line 2a on the face page of the application.



Submit a signed, typewritten original of the application, including

the Checklist, and four signed, exact photocopies, in one package:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



At the time of submission, one additional copy of the application

must also be sent to:



Ms. Toby Friedberg

Division of Extramural Activities

National Cancer Institute

Executive Plaza North, Room 636A

6130 Executive Boulevard

Bethesda, MD  20892



The application must meet the requirements listed below.



The Research Plan of the application is limited to 16 pages total.  A

suggested page limitation is as follows:



o  Specific Aims - one page

o  Background, Significance, and Preliminary Studies - five pages

o  Research Design and Methods - 10 pages



Following the research plan, include the discussion of Human Subjects

and the literature cited.  Human subjects approval and IRB approval

of clinical protocols must be obtained prior to review.

Documentation for the composition of the proposed study population in

terms of gender and racial/ethnic group together with a rationale for

its choice must be included in the Human Subjects section.  The

clinical protocol must be included in the Appendix.



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established PHS

referral guidelines.  Applications will be reviewed for scientific

and technical merit by an appropriate review group at the Division of

Extramural Activities, National Cancer Institute.  Foreign grant

applications will also be reviewed by the National Cancer Advisory

Board.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to the NCI.  The following will be considered

in making funding decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



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:



Ms. Diane Bronzert or Dr. Roy Wu

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

Bethesda, MD  20892

Telephone:  (301) 496-7800, ext. 56

FAX:  (301) 496-8601



AUTHORITY AND REGULATIONS



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 PHS grants policies and Federal

Regulations at 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.



.

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