This Program Announcement expires on July 31, 2004, unless reissued.

NINDS CLINICAL TRIAL PLANNING GRANT

Release Date:  July 25, 2001 (see replacement PAR-03-051)

PA NUMBER:  PAR-01-118

National Institute of Neurological Disorders and Stroke

THIS PAR USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR INSTRUCTIONS 
MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR.  MODULAR 
BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) 
AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html.

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.

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.  
Included in the planning grant application must be an outline of the projected 
direct cost of the phase III clinical trial that would follow on the planning 
phase study.  This estimate, broken down by year, should be included in the 
research plan of the application.

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.
 
ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign 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.

INQUIRIES

Inquiries concerning this PAR are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

John R. Marler, M.D.
Associate Director for Clinical Trials
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2216
Bethesda, MD 20892-9520
Telephone:  (301) 496-9135
Fax:  (301) 480-1080
Email:  jm137f@nih.gov

Barbara Radziszewska, Ph.D., M.P.H.
Clinical Research Project Manager
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2216
Bethesda, MD 20892-9520
Telephone:  (301) 496-2076
Fax:  (301) 480-1080
Email: br94h@nih.gov

Direct inquiries regarding review issues to:

Lillian Pubols, Ph.D.
Chief, Scientific Review Branch
NSC/NINDS/NIH
6001 Executive Boulevard
Bethesda, MD 20892-9529
Telephone:  (301) 496-5324
Fax:  (301) 402-0182
E-mail:  lp28e@nih.gov

Katherine Woodbury Harris, Ph.D.
SRA, Scientific Review Branch
NSC/NINDS/NIH
6001 Executive Boulevard
Bethesda, MD 20892-9529
Telephone:  (301) 496-5980
Fax:  (301) 402-0182
E-mail:  kw47o@nih.gov

Direct inquiries regarding fiscal matters to:

Gladys Melendez-Bohler
Senior Grants Management Specialist
NIH/NINDS/GMB/Suite 3290
6001 Executive Blvd.
Rockville, MD 20892
Telephone: (301) 496-9231
Fax:  (301) 402-0219
Email:  bohlerg@ninds.nih.gov

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format. Although applicants are encouraged to begin using the 
5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to 
accept applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that are 
not submitted on the 5/2001 version.  For further assistance contact GrantsInfo, 
Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended/revised version of 
the preceding grant application types requesting $500,000 or more in direct 
costs for any year are advised that he or she must contact the Institute or 
Center (IC) program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from the IC staff that the IC will accept the application for 
consideration for award.  Finally, the applicant must identify, in a cover 
letter sent with the application, the staff member and Institute or Center who 
agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of the 
original application as well as any subsequent revisions.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs may 
be requested as well as a maximum level for requested budgets. Only limited 
budgetary information is required under this approach.  The just-in-time concept 
allows applicants to submit certain information only when there is a possibility 
for an award. It is anticipated that these changes will reduce the 
administrative burden for the applicants, reviewers and NIH staff.  The research 
grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in Section 
C of the application instructions.  Applicants are permitted, however, to use 
the 4/1998 revision of the PHS 398 for scheduled application receipt dates until 
January 9, 2002.  If you are preparing an application using the 4/1998 version, 
please refer to the step-by-step instructions for Modular Grants available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Additional 
information about Modular Grants is also available on this site.

The title and number of the program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express mail or courier service)

In order to facilitate the review of applications assigned to the NINDS, the 
applicant should, at the same time, mail or deliver two copies of the 
application to:
 
Dr. Lillian Pubols
Chief, Scientific Review Branch
NINDS, NIH
6001 Executive Boulevard
Bethesda, MD 20892-9529
Rockville, MD 20852 (Courier service only)
EMAIL:  lp28e@nih.gov

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 should 
be included with the application.

REVIEW CONSIDERATIONS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NINDS.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration.

Applications that are complete and responsive to the PAR will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NINDS in accordance with the review criteria stated below.  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 the applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the NINDS National Advisory Council.

Review Criteria

(1) Rationale.  Is there adequate information to determine the significance and 
need to perform a future full-scale randomized clinical trial (RCT)?  Are 
adequate reasons presented for selection of intervention and mode of delivery, 
and for selecting particular doses or procedures?  Is there adequate information 
provided regarding the biological mechanisms and clinical data that support 
conducting an RCT?  Did the applicant present a compelling case for a need to 
proceed with an RCT as soon as possible?  Did the applicant adequately explain 
the impact of the future RCT on health care?  Was there adequate discussion 
included of advantages and disadvantages of competitive therapies?  Is the 
discussion of the ethical issues surrounding an RCT and the disease under study 
complete and thorough, and are there adequate safeguards in place to protect the 
welfare of human subjects?   

 (2) Experimental Design.  Are the conceptual framework, design, methods, and 
analyses adequately developed and appropriate for the aim of the future RCT?  In 
evaluating the experimental design, the reviewers will consider the adequacy of 
the following: translation of the clinical question into a statistical 
hypothesis; sample size and duration of the RCT; selection of endpoint(s) and 
data to be collected; randomization and masking; and inclusion/exclusion 
criteria; 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. Are there adequate plans for 
documenting the availability of the requisite eligible patient pool and for 
including women, children, and minority individuals, (as appropriate) as trial 
participants?  Has the applicant provided adequate plans for recruitment 
outreach, as appropriate, and for follow-up procedures to ensure collection of 
data at stated intervals?

(4) Investigators.  Is there 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?  Is there 
evidence of professional training and experience of the RCT organizers in such
areas as the clinical problem under study, administration of complex projects, 
and study design?  Are there plans for inclusion of statisticians, data managers 
and study coordinators? Has the applicant developed plans to add or drop 
centers?  Are there adequate plans for essential committee structure, i.e., 
Planning, Steering, and Executive committees?

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, program priority, and program balance.

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 
sub-populations must be included in all NIH-supported biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification are provided indicating 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  This 
policy applies to all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in a NIH solicitation, 
Internet addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the Internet sites.  
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances. Data that are (1) first produced in a project 
that is supported in whole or in part with Federal funds and (2) cited publicly 
and officially by a Federal agency in support of an action that has the force 
and effect of law (i.e., a regulation) may be accessed through FOIA. It is 
important for applicants to understand the basic scope of this amendment. NIH 
has provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this RFA (PA) in a public 
archive, which can provide protections for the data and manage the distribution 
for an indefinite period of time. If so, the application should include a 
description of the archiving plan in the study design and include information 
about this in the budget justification section of the application. In addition, 
applicants should think about how to structure informed consent statements and 
other human subjects procedures given the potential for wider use of data 
collected under this award.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This PA, “NINDS CLINICAL TRIAL PLANNING 
GRANT”, is related to the priority area of chronic and disabling conditions.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.853.  Awards are made under authorization of sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 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, 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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