Full Text PAR-97-102
 
NINDS CLINICAL TRIAL PLANNING GRANT
 
NIH Guide, Volume 26, Number 29, August 29, 1997
 
PA NUMBER:  PAR-97-102
 
P.T.


Keywords: 

 
National Institute of Neurological Disorders and Stroke
 
PURPOSE
 
The NINDS seeks to fund high quality clinical trials to evaluate
treatments for neurological disorders.  The NINDS Clinical Trial
Planning Grant allows for early peer review of the rationale and
design for clinical trials of treatments for neurological disorders
and provides support for the development of a detailed clinical trial
research plan, including a complete manual of operations and
procedures.
 
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, THE
NINDS CLINICAL TRIAL PLANNING GRANT, 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 will be the Developmental Planning Grant
(R21), which will provide up to $150,000 in direct costs for a single
year.  The award cannot be renewed.
 
RESEARCH OBJECTIVES
 
The NINDS encourages clinical research to evaluate interventions to
treat and prevent neurological disease.  The NINDS has established
the Clinical Trial Planning Grant because extensive efforts are
required to develop a detailed study protocol and to organize an
effective research group.  After the basic design and rationale for a
neurological treatment trial has been reviewed, the NINDS Clinical
Trial Planning Grant supports the development of specific elements
which will be essential to conducting a successful full-scale
clinical trial, including adequate plans for recruitment of patients,
experimental design and protocols, data management, analytical
techniques, facilities, administrative procedures, and collaborative
arrangements.
 
Detailed information regarding the rationale of the clinical trial,
based on adequate, preclinical science and preliminary clinical
research, must be developed prior to submission and included in the
application for a Clinical Trial Planning Grant.  The purpose of the
planning grant is not to obtain preliminary data or to conduct
studies to support the rationale for the clinical trial.  The
expected product of the planning grant is a detailed clinical trial
research plan including a complete manual of operations and
procedures.
 
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 Public
Health Service 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.  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:
 
All applications will be reviewed using the criteria below:
 
(1) Rationale.  The background and significance of the application
must address the rationale for a future, full-scale, randomized
clinical trial (RCT)  including:
 
- reasons for selection of intervention and mode of delivery
including specific details such as dose or a particular procedure; -
the biological mechanisms and clinical data that support conducting
an RCT;
- information adequate to determine the significance and need to
perform an RCT;
- compelling need to proceed with an RCT as soon as possible; impact
on health care;
- competitive therapies--advantages and disadvantages; - ethical
issues surrounding an RCT and the disease under study; - a clear
statement of the question that an RCT would address.
 
(2) Experimental Design.  The application for a planning grant will
include a full description of the experimental design of the future
RCT, including:
- translation of the clinical question into a statistical hypothesis;
- sample size and duration of the RCT;
- endpoint(s) and data to be collected;
- randomization, masking, and inclusion/exclusion criteria; - the
strengths and weaknesses of the proposed methods, and possible
alternatives;
- ancillary therapies
- capability to develop methods for standardization of procedures for
data management and quality control.
 
(3) Plans to Address Patient Recruitment/Retention. The application
must address the following items:
- plans for documenting the availability of the requisite eligible-
patient pool;
- plans for including women and minority individuals as trial
participants
- and plans for recruitment outreach, as appropriate; follow-up
procedures to ensure collection of data at stated intervals.
 
(4) Investigators.  The application must include a clear statement of
the leadership and proposed organization of the RCT, including: -
identification of a principal investigator, and for multi-center
trials, a core of potential center investigators;
- professional training and experience of the RCT organizers in such
areas as the clinical problem under study, administration of complex
projects, and study design.
- inclusion of statisticians, data managers and study coordinators; -
plans to add or drop centers;
essential committee structure, i.e., Planning, Steering, Executive.
 
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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