CLINICAL TRIAL METHODS IN NEUROLOGY REQUEST FOR INFORMATION (RFI): NS 04-015

RELEASE DATE:  August 19, 2004

NOTICE:  NOT-NS-04-015

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)

The National Institute of Neurological Disorders and Stroke (NINDS) is 
considering issuing a contract to develop a course of intensive 
training in clinical trial methodology for neurology research.   NINDS 
is attempting to identify sources with experience and expertise to 
develop and coordinate the scientific design and implementation of 
such training.  

Background

The proposed idea is for development and implementation of a short 
course in clinical trial methodology targeted to junior 
neurology/neurosurgery faculty and fellows.  Good design and conduct 
of clinical trials can provide definitive answers about the 
effectiveness of new therapeutic approaches.  This can lead to 
promising avenues of research that are based on sound basic scientific 
work and lead to the introduction of new treatments into the general 
practice of neurology and neurosurgery.  The field of neurology 
clinical trials is still fairly young and there is a need for more 
medically-trained researchers with appropriate methodological 
training.  Currently, training in clinical research methodology that 
is typically provided by undergraduate and post-graduate medical 
education programs and fellowships is not adequate for developing 
future leaders in neurology clinical trials.  The proposed course is 
intended to provide the essential basics that will help the trainees 
make the transition from an interesting research question to a well-
planned research protocol.

Similar courses in other disciplines (e.g., oncology, cardiovascular 
disease) often incorporate lectures, panel discussions, and working 
sessions over an intensive training period of 1 to 2 weeks.  The 
course agenda for this program is intended to focus on general as well 
as neurology-specific concepts in clinical trials design and conduct 
and to provide students with hands-on experience in developing a 
clinical trials protocol.  Neurology and neurosurgical clinical 
fellows and junior faculty will be invited to apply to attend the 
course.  To be most effective, we expect the training course to be 
conducted at least annually.  Evaluation of course quality and impact 
will be a significant component of the proposed initiative, with the 
results to be incorporated into subsequent years’ programs and 
curricula.  We also want to stress the importance of methodology and 
training in minority populations and investigators.  
         
It is anticipated that this course will yield a group of talented, 
dedicated neurology researchers who will consequently be in a position 
to obtain funding for their own high quality clinical research.  If 
the program is successful, it is anticipated that trainees will return 
to their academic departments where they will take a prominent role in 
advancing local research priorities in neurology.     
         
Goals of the Contract

The purpose of such a “Clinical Trial Methods in Neurology” course is 
to increase the reliability and effectiveness of clinical trials by: 
introducing clinical fellows and junior faculty in any neurology or 
neurosurgical subspecialty to the principles of good clinical trial 
design; exposing early career clinical scientists to the full spectrum 
of challenges in clinical research; and developing a cadre of well-
trained, experienced clinical researchers whose expertise will foster 
better clinical trials design and thereby hasten the introduction of 
improved regimens for therapy and prevention of neurological disorders 
into everyday medical practice and patient care.  

Specific goals of the contract are:

1.  To develop scientific content, curriculum, and format of the 
training program.
2.  To organize and conduct the training program, including 
recruitment and selection of faculty and participants.
3.  To conduct formal evaluation of the training program.

Information Requested

Information in the following areas will aid in the design of the 
proposed solicitation.  We ask that interested organizations identify 
critical criteria to be included in the solicitation.  The information 
supplied in response to this request need not be limited to these 
areas.

o General scientific approach to identifying content and developing 
and implementing the training program; 
o General scientific approach to on-going evaluation of the training 
program;
o Overall estimation of the number of personnel required and specific 
expertise needed, with approximate level of effort required for each;
o Availability of technology;
o Project timeline;
o Your organization’s capability as it relates to this project.

This Request for Information (RFI) is for information and planning 
purposes only and shall not be construed as a solicitation or as an 
obligation on the part of the Government.  The Government does not 
intend to award a contract on the basis of responses nor otherwise pay 
for the preparation of any information submitted or the Government’s 
use of such information.  Acknowledgement of receipt of responses will 
not be made, nor will respondents be notified of the Government’s 
evaluation of the information received.  However, should such a 
requirement materialize, no basis for claims against the Government 
shall arise as a result of a response to this request for information 
or the Government’s use of such information as either part of our 
evaluation process or in developing specifications for any subsequent 
requirement.  Responses will be held in a confidential manner.  Any 
proprietary information should be so marked.

All respondents are asked to indicate the type and size of your 
business organization, e.g., Large Business, Small Business, Veteran-
owned Small Business, Service-disabled Veteran-Owned Small Business, 
Hubzone Small Business, Small Disadvantaged Business, Women-Owned 
Business, 8(a), Historically Black College or University/Minority 
Institution (HBCU/MI), educational institution, profit/non-profit 
hospital, or other nonprofit organization.

Responses should be identified with NINDS RFI No. 04-015 and are due 
by September 9, 2004.  Please submit four (4) copies of your response 
to: 

Ida Lirette 
Contract Specialist

or 

Laurie Leonard
Contracting Officer 

Contracts Management Branch 
National Institute of Neurological Disorders and Stroke 
NIH
6001 Executive Boulevard, Room 3287 MSC 9531 
Bethesda, Maryland 20892-9531.  
(for FedEx or courier, use: Rockville, MD 20852)

Phone number: (301) 496-1813
Fax number: (301) 402-4225
E-mail responses, sent to il26v@nih.gov, will also be accepted.

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