Full Text PAR-97-006
 
SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES
 
NIH GUIDE, Volume 25, Number 37, November 1, 1996
 
PA NUMBER: PAR-97-006
 
P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Clinical Trial 

 
National Cancer Institute
 
Application Receipt Dates:  May 15, September 15, January 15
 
PURPOSE
 
The Division of Cancer Treatment Diagnosis and Centers(DCTDC),
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
in patients or do pilot clinical studies.
 
This PA supersedes PAR-95-023, Small Grants for Therapeutic Clinical
Trials of Malignancies, which was published in the NIH Guide for
Grants and Contracts, Vol. 24, No. 3, January 27, 1995.
 
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
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202/512-1800).
 
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. 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 (not to exceed 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 clinical
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, DCTDC, 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
test 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 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.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  Applications must be received by the following
receipt dates: May 15, September 15, and January 15. Application kits
are available at most institutional offices of sponsored research and
may be obtained from the Office of Extramural Outreach and
Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone (301) 710-0267, email:
[email protected].  The title and number of this Program
Announcement must be typed in Section 2 on the face page of the
application.
 
Submit a signed, typewritten original of the application, and three
signed, exact photocopies, in one package:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040  MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must also be sent to:
 
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892
Rockville, MD  20852 (for express mail)
 
Special Instructions for the Completion of the PHS 398 Application
 
"Just-in-time" (JIT) is an initiative of the National Institutes of
Health (NIH) Extramural Reinvention Laboratory under the auspices of
the National Performance Review and government-wide efforts to create
a government that works better and costs less. JIT postpones the
collection of certain information that currently must be included in
all competing applications when submitted.  The information for the
applications with a likelihood of funding is submitted "just-in time"
for awards to be made.  This program announcement is incorporating
JIT procedures as described below.
 
In responding to the program announcement, the instructions given
below should replace the normal instructions for specific sections of
the PHS 398 application form (rev. 5/95).  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 your
application receives a priority score in the fundable range.  For all
other items in the application, follow the usual instructions in the
PHS 398 booklet.
 
FACE PAGE (Form AA) - The title and number of the PA must be typed in
line 2.  Failure to do so could result in delayed processing of your
application such that it may not reach the review committee in time
for review.  The Social Security Number (SSN) of the Principal
Investigator should not be included on the Face Page.  It should be
provided along with the applicant's name at the top of the Personal
Data form page only (Form KK).
 
FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD Do
not complete form page 4 of the PHS 398 (rev. 5/95).  It is not
required nor will it be accepted at the time of application.
 
Form EE - Page 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do not
complete the categorical budget table on form page 5 in the PHS 398
(rev. 5/95).  Only the requested total direct costs for each year and
total direct costs for the entire proposed period of support should
be shown.  Begin the budget justification in the space provided,
using continuation pages as needed.
 
Budget Justification
 
o List the name, role on project and percent effort for all project
personnel(salaried or unsalaried) and provide a narrative
justification for each person based on his/her role on the project
and proposed level of effort.
 
o Identify all consultants by name and organizational affiliation and
describe the services to be performed.
 
o Provide a narrative justification for any major budget items, other
than personnel, that are requested for the conduct of the project
that would be considered unusual for the scope of research.  No
specific costs for items or categories should be shown.
 
o Indirect costs will be calculated at the time of the award using
the institution's actual indirect cost rate.  Applicants will be
asked to identify the indirect cost exclusions prior to award.
 
o If consortium/contractual costs are requested, provide the
percentage of the subcontract total costs (direct and indirect)
relative to the total direct costs of the overall project.  The
subcontract budget justification should be prepared following the
instructions provided above.
 
Form FF - Page 6- BIOGRAPHICAL SKETCH
 
A biographical sketch is required for all key personnel, following
the modified instructions below.  Do not exceed the two-page limit
for each person.
 
o  Complete the education block at the top of the form page;
o  List current position(s) and those previous positions directly
relevant to the application;
o  List selected peer-reviewed publications directly relevant to the
proposed project, with full citation;
o  Provide information on research projects completed and/or research
grants participated in during the last five years that are relevant
to the proposed project.  Title, principal investigator, funding
source, and role on project must be provided.
 
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 15-19) -
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
16-17 of the PHS 398 booklet.  The 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 which 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 17-18.  State clearly the plans for early
detection of and protection against adverse effects on human
subjects.  Describe the composition of the proposed study population
in terms of gender and racial/ethnic group, and provide a rationale
for selection of such subjects.  Use a format like the Annual Report
Format for Gender and Minority Inclusion on pg. 31.
 
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 (Page 19) - Up to five publications,
manuscripts submitted or accepted for publication, patents, invention
reports should be provided.  Clinical protocol(s) must be included in
this section.
 
SPECIFIC INSTRUCTIONS - CHECKLIST (Form II) - 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, please contact 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 program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group in accordance with review criteria
stated below.  As 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 and assigned a priority score.
 
Review Criteria
 
o Importance, timeliness, and clinical merit of the clinical trials
 
o Scientific and technical merit and relevance of proposed patient
monitoring or laboratory studies
 
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 Quality of data verification and management plans and statistical
analysis
 
The initial research group will also examine 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.
 
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:  [email protected]
[email protected]
 
Direct inquiries regarding fiscal matters to:
 
Ms. Victoria Price
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 252
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 56
FAX:  (301) 496-8601
Email:  [email protected]
 
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 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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