Full Text PAR-97-103
 
PILOT CLINICAL TRIAL GRANT FOR NEUROLOGICAL DISEASE
 
NIH Guide, Volume 26, Number 29, August 29, 1997
 
PA NUMBER:  PAR-97-103
 
P.T.


Keywords: 

 
National Institute of Neurological Disorders and Stroke
 
PURPOSE
 
The NINDS is committed to identifying effective treatments for
neurological disorders by supporting well-executed clinical trials.
Before proceeding to a full-scale clinical trial, pilot clinical
studies are often required.  The NINDS announces its interest in
supporting pilot studies required to obtain necessary information to
clearly establish the clinical basis for proceeding to a full-scale
trial.  The purpose of NINDS Pilot Clinical Trial Grant For
Neurological Disease is to obtain preliminary data and conduct
studies to support the rationale for a subsequent full-scale clinical
trial of an intervention to treat or prevent neurological disease.
 
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,
NINDS PILOT CLINICAL TRIAL GRANT FOR NEUROLOGICAL DISEASE, is related
to the priority area of chronic disabling conditions.  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 and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
 
MECHANISM OF SUPPORT
 
The mechanism of support for the NINDS Pilot Clinical Trial Grant is
the research project grant (R01).  It is expected that most grants
will not exceed $350,000 per year in direct costs for 3 years.
 
RESEARCH OBJECTIVES
 
The research project should directly address how the Pilot Grant will
advance the design of a subsequent full-scale clinical trial.  The
application should also address the intrinsic scientific merit of the
study conducted under the Pilot Grant, whether or not a full-scale
trial is performed.
 
The NINDS Pilot Clinical Trial Grant may include:
-Studies to refine the intervention strategy (dosage, duration,
delivery system)
-Studies to define and refine the target population
-Collection of preliminary data for establishing measures of efficacy
and safety
 
In preparing for the definitive clinical trial, a pilot study will
address questions that are formulated to optimize the design of the
eventual trial rather than address the clinical question with lower
power.
 
The objective of the NINDS Pilot Clinical Trial Grant is to increase
the quality of clinical research to evaluate interventions for the
treatment or prevention of neurological disease.  To meet this
objective the proposed pilot study must successfully incorporate
creative and realistic solutions to difficult problems in clinical
neurological research for the particular intervention being
evaluated.
 
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 policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
 
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 20, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Vol. 23, No. 11, March 28, 1994.
 
APPLICATION PROCEDURES
 
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 Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov. The title and number of the program
announcement must be typed in Section 2 on the face page of the
application.  As with most applications to NIH, the research plan is
limited to 25 pages.  All information for review of the NINDS
Clinical Trial Planning Grant application must be included in the
body of the application; appendices will not be considered during the
review for this mechanism.
 
The completed original application and four legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892
BETHESDA, MD  20817 (for express/courier service)
 
In order to facilitate the review of applications assigned to the
NINDS, the applicant should, at the same time, mail or deliver one
copy of the application to:
 
Dr. Lillian Pubols
Chief, Scientific Review Branch
NINDS, NIH
Federal Building, Room 9C10
7550 Wisconsin Avenue
Bethesda, Maryland 20892-9175
EMAIL:  lp28e@nih.gov
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications that are complete will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with the standard NIH peer review
procedures.  For applications given primary assignment to the
National Institute of Neurological Disorders and Stroke, the initial
peer review group will be convened by the Institute.  As part of the
initial merit review, all applications will receive a written
critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of applications under review, will be discussed, assigned a priority
score, and receive a second level review by the appropriate national
advisory council or board.
 
Review Criteria for research grant applications:
 
The goals of NIH-supported research are to advance our understanding
of biological systems, improve the control of disease, and enhance
health.  In the written review, comments on the following aspects of
the application will be made in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit
of these goals.  Each of these criteria will be addressed and
considered in the assignment of the overall score.
 
(1) Significance.  Does this study address an important problem?  If
the aims of the application are achieved, how will scientific
knowledge be advanced?  What will be the effect of these studies on
the concepts or methods that drive this field?  In addition, the
following must be addressed:
- The state of equipoise in the medical and patient communities - The
scientific basis for the proposed intervention including discussion
of current practice and alternative interventions - Impact of the
proposed intervention on health care and quality of life
 
(2) Approach.  Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to
the aims of the project?  Does the applicant acknowledge potential
problem areas and consider alternative tactics?  The following should
be addressed:
 
(a) Study Design and Procedures.
- Sequence of clinical studies, including the proposed pilot study,
that will produce a definitive clinical trial
- Translation of the clinical question into statistical hypotheses -
Selection of outcome measure(s)
- Inclusion and exclusion criteria
- Secondary questions (including capacity for post hoc analyses) -
Detailed protocol with standardized procedures that will be used for
this pilot study
- Ethical and safety issues, and quality control procedures -
Necessity for randomization and masking
 
(b)Data Analysis
- Specific methods to be used for data analysis
- The sample size for the pilot study may not be adequate to detect
any but the largest treatment differences; however, the data from
this study should provide a basis for providing sample size estimates
for future trials.
- Population and demographics of the clinical condition
 
(3) Innovation.  Does the project employ novel concepts, approaches
or method?  Are the aims original and innovative?  Does the project
challenge existing paradigms or develop new methodologies or
technologies?
 
(4) Investigator. Is the investigator appropriately trained and well
suited to carry out this work?  Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers (if any)?  The following should be addressed: - Training
and expertise in the clinical problem and the proposed intervention
- Training and expertise in clinical trials
 
(5) Environment.  Does the scientific environment in which the work
will be done contribute to the probability of success?  Do the
proposed experiments take advantage of unique features of the
scientific environment or employ useful collaborative arrangements?
Is there evidence of institutional support?
 
In addition, the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific
goals of the research will be reviewed.  Plans for the recruitment
and retention of subjects will also be evaluated.
 
The initial review group will also examine the provisions for the
protection of human 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 that IC.  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
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Joseph S. Drage, M.D.
Training and Special Programs Officer,
National Institute of Neurological Disorders and Stroke Telephone:
(301) 496-4188
FAX:  301-402-0302
Email:  jd66x@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Angeline Wilson
Grants Management Branch
National Institute of Neurological Disorders and Stroke Telephone:
(301) 496-9231
FAX:  301-402-0219
Email:  aw45j@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.853.  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.
 
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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