Full Text PAR-95-023

SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES

NIH GUIDE, Volume 24, Number 3, January 27, 1995

PA NUMBER:  PAR-95-023

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 small grants program to encourage the submission of
small grant applications for new 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 clinical studies.

This PA supersedes PAR-94-50, Small Grants for Therapeutic Clinical
Trials of Malignancies, that was published in the NIH Guide for
Grants and Contracts, Volume 23, Number 10, March 11, 1994.

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 of Malignancies, 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 several institutions
(collaborating institutions, consortia, clinical trials cooperative
groups), if appropriate.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators.

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 will compete for funds with all
other R03 grant applications assigned to the NCI.  The award of
grants in response to this program announcement 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 (rev. 4/94).

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 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.  Investigators
should be able to identify sufficient numbers of patients to complete
the trial in a timely manner.

Laboratory studies may also be proposed to conduct pharmacokinetic,
pharmacodynamic, immunologic, 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.


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 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 nd 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.

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.  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 301/435-0714.  The title and
number of this program announcement must be typed in Section 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
Bethesda, MD  20892

Special Instructions for the Completion of the PHS 398 Application

The NIH has recently been designated a "reinvention laboratory" by
the Public Health Service.  One component of our efforts to
streamline NIH operations is to simplify the grant application and
review process.

Therefore, an experiment is being conducted to determine ways to
reduce the administrative burden in applying for an NIH grant without
compromising those elements needed by the initial scientific peer
review group to assess the scientific merit of the application and
the reasonableness of the proposed budget.

In responding to this program announcement, the following are
specific instructions for sections of the PHS 398 application form
(rev. 9/91) that should be completed differently from usual.  Some
sections are modified and others in the application do not need to be
completed for the submission of the application but WILL be requested
if the application receives a priority score in the fundable range.
For all other items in the application, follow the usual instructions
on pages 9-32 of the PHS 398 booklet.

FACE PAGE (Form AA) - The title and number of the PA must be typed in
line 2a.  Failure to do so could result in delayed processing of the
application such that it may not reach the review committee in time
for review.

Item 10, INVENTIONS AND PATENTS - Do not complete.  See Specific
Instructions - Appendix for Instructions.

FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD -
Enter direct costs only for the following:

o  Personnel, Patient Care Costs, Alterations-Renovations - Complete
these sections as instructed in the PHS 398 booklet.

o  Consultant Costs - Itemize only if proposed consultant costs
exceed $10,000 or if a consultant is identified as key personnel.

o  Equipment - Itemize only individual equipment items in excess of
$10,000.

o  Supplies - Itemize (a) all animal costs and (b) any individual
supply item which costs more than $10,000.  If animals are involved,
state their unit purchase and care costs.  Enter total animal costs
and supply costs on separate lines.

o  Travel and Other Expenses - Itemize any expense category that
exceeds $5,000.

Form EE - Page 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do not
complete this page.  Future years will be automatically escalated on
the direct costs proposed for the first year (minus one time costs
for equipment) by four percent unless you are requesting unusual
increases or decreases in future years.

Form FF - Page 6 - BIOGRAPHICAL SKETCH  For each KEY person only,
provide a two-page biographical sketch.

Name, Position Title, Education - Complete these sections as
instructed in the PHS 398 booklet.

Research and Professional Experience - Identify your research
background and experience relevant to the research proposed.
Specifically, provide:

o  A list of previous research positions that are felt to be of
significance or relevance for the review of the proposed research;

o  Complete references, titles, and authors on all peer-reviewed
publications representative of your research career or pertinent to
the research proposed;

o  The title and funding source of all active research grants or
contracts on which you are principal investigator, co- investigator,
or project leader.  Indicate current percent effort for each award.

o  The title and length of service on any peer review group, council,
or program advisory committee.

Form GG - Page 7 - OTHER SUPPORT - Do not complete.  Updated
information will be requested by NCI staff from only those applicants
being considered for funding.

Form HH - Page 8 - RESOURCES AND ENVIRONMENT - Complete item(s) only
if proposed research requires specialized resources unique for the
proposed research.

SPECIFIC INSTRUCTIONS - Research Plan (Booklet pages 19-24) -
Applications in response to this PA should be concise and
substantially shorter than regular grant applications.  Items 1-4 may
not exceed 16 pages in total.

Item 1 - Specific Aims - In one page or less, list in priority order,
the broad, long-range objectives. Describe concisely and
realistically the hypothesis to be tested and what the specific
research described in this application is intended to accomplish.

Item 2 - Background and Significance - In three pages or less, use
this section to describe (a) how the proposed research will
contribute to meeting the goals and objectives of the PA; and, (b)
explain the rationale for the selection of the general methods and
approaches proposed to accomplish your specific aims.

Items 3-4 - Progress Report/Preliminary Studies, Research Design and
Methods - In twelve pages or less, complete as instructed on pages
20-21 of the PHS 398 booklet with the modification that the clinical
protocol(s) and up to three publications, manuscripts submitted or
accepted for publication, patents, or invention reports can be
included in the Appendix (see below).

Investigator may use this section to address the following:

o  preliminary studies pertinent to the application;

o  rationale and hypothesis for the clinical trial and laboratory
studies.

o  general methods that will be utilized; provide specific details
for those techniques that are unique or where a significant departure
from a generally accepted technique is important for reviewers to
know;

o  outcome measures that will be used to assess the success or
failure of each set of experiments (include statistical analyses for
laboratory and clinical studies);

o  plans for the rigorous data management and verification of
research data;

o  potential pitfalls in the experimental design and alternative
studies that will be done if the proposed experiments fail.

Items 5-6 - Human Subjects, Vertebrate Animals - Complete as
described on pages 22-23.  State clearly the plans for early
detection of and protection against adverse effects on human
subjects.

Item 7 - Consultants/Collaborators - Biographical sketches should
conform to the brief format described previously for Form FF.

Item 8 - Consortium, Contractual Arrangements - In one page or less,
provide a brief explanation of the programmatic fiscal, and
administrative arrangements made with collaborating organizations.

Item 9 - Literature Cited - In two pages or less, give full
literature citations including the title of the article.

SPECIFIC INSTRUCTIONS - Appendix (Booklet page 24) - Up to three
publications, manuscripts submitted or accepted for publication,
patents, invention reports should be provided. Clinical protocol(s)
must be included in this section.  Other than this change, complete
as instructed.

SPECIFIC INSTRUCTIONS - CHECKLIST (Forms II and JJ) - Do not
complete.  Information will be requested by NCI staff from only those
applicants being considered for funding.

If you or your business office have any questions regarding these
instructions, contact the program staff listed under INQUIRIES.

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, in accordance with
standard peer review procedures.  Foreign grant applications will
also be reviewed by the National Cancer Advisory Board.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group in accordance with review criteria stated below.  s part
of the initial merit review, all applications 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 advisory council or board.

Review Criteria

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

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial research group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

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:  Quality of the proposed project as
determined by peer review, availability of funds, and program
priority.

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
Email:  BRONZERTD@DCT.NCI.NIH.GOV

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.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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