RELEASE DATE:  February 6, 2003

NOTICE:  NOT-NS-03-006

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) is 
considering issuing a contract for development of a Clinical Research 
Collaboration (CRC) Facility to assist with the efficient execution of 
clinical trials and other types of NINDS-sponsored clinical research.  
NINDS is seeking input about the technical expertise required and 
available to create and operate an efficient CRC Facility, as well as 
input into its specific structure and design.


Recent progress in neuroscience has led to an explosion in neurological 
treatments that require testing in randomized clinical trials to 
determine their efficacy and safety.  Conventional approaches to 
recruitment and follow-up of participants employed in recent NINDS-
sponsored trials are slow and inefficient: a recruitment/follow-up 
infrastructure is developed de novo for individual trials, typically 
involving a limited number of academically-based neurologists, with 
recruitment lasting several years.  

The overall objective of the NINDS CRC Facility is to facilitate the 
efficient execution of NINDS-sponsored clinical research in order to 
test more treatments, more expeditiously.  Within the CRC Facility, 
hundreds of academic-based and practice-based neurologists will recruit 
and follow patients through access to multiple clinical trial 
protocols.  The CRC Facility will assist investigators holding NINDS 
grants with the execution of clinical research and with involving the 
broadest possible range of patients and physicians.  The CRC Facility 
will be a web-based network, distinctly different from traditional 
disease-specific investigator research networks.  The CRC Facility will 
serve as the switchboard to coordinate clinical research projects 
developed and funded by independent NINDS-supported investigators.  
There will be multiple pathways to CRC Facility access, several levels 
of physician participation, the flexibility to adapt to the needs of 
specific research studies, and ongoing continuing medical education 
(CME) as a prominent component. 

The major aims of the CRC Facility are:

1. to expedite recruitment (achieving goals in months rather than years).
2. to involve a wide spectrum of investigators, especially practicing 
3. to recruit a broad range of participants, particularly minorities.
4. to minimize the cost of the infrastructure, so that overall 
cost/participant are not increased.
5. to make participation in NINDS clinical research more accessible to 
6. to facilitate the transfer of research results to clinical practice, 
especially to  community settings.
7. to encourage large, streamlined trial designs, particularly relevant 
for studies of primary prevention of neurological diseases. 
8. to maintain quality by peer-review of competitive investigator-
initiated studies.
9. to make study of "small neurological diseases" economically feasible.
10. to engender a tradition of  participation in clinical research and 
of evidence-based therapeutics among neurologists.

These aims must be achieved while maintaining the highest ethical 
standards in human subject research, setting a benchmark for the entire 
neurology research community.

Further details about our ideas regarding the proposed CRC Facility are 
found in Appendix I, derived from input received at the NINDS Clinical 
Research Collaboration Workshop: Exploring the Options (October 7-8, 
2002).  Appendix I can be obtained via email request to Desiree 
Wheeler, Contract Specialist, NINDS at  Proposals for 
alternative structures to achieve the aims above are solicited as part 
of this RFI.

Information Requested

Information in the areas listed below will aid in the design of a 
solicitation to establish and operate a CRC Facility.  We request that 
interested organizations identify their technical expertise and 
resources, and capabilities and describe their availability to conduct 
such an endeavor. 

1.  Design and structure of the CRC Facility

i. What are the major essential components of the CRC Facility?  What 
expertise, capabilities, and levels of effort are required?
ii. How can continuing medical education (CME) be effectively 
integrated into the CRC Facility for training and investigator 
motivation?  What technical, medical, and other professional expertise 
is required to implement the CME?
iii. What steps (or phases) are necessary for initiation of the CRC 
Facility?  What is the proposed timeline?
iv. Given a perceived need for more information about 
motivation/barriers to CRC Facility participation by practicing 
neurologists, academic neurologists and patients with neurological 
diseases, if and how should focus group data be used to this end, and 
what resources would be required?
v. What scientific and technical resources are required to initiate a 
website to efficiently link eligible patients and physicians to NINDS-
sponsored clinical research projects, including assess eligibility on-
vi. How can access to children, women and minority participants be 
vii. What would be the critical mass necessary to use, operate and 
maintain such a facility?

2. Subcontract Award and Management

CRC Facility research may involve hundreds of investigators funded 
through awards issued by the contractor as subcontracts.  Describe the 
personnel and database requirements associated with awarding and 
managing multiple subcontracts, including quality control procedures 
and research support services.

3. Program Management and Evaluation

Initiating the CRC Facility will be a complex and multifaceted process.  
The contractor will additionally be required to evaluate the progress 
of the subcontracted research and of the efficiency of the CRC 

i. Describe your experience with strategic planning and initiation of 
comparably complex projects.

ii. Describe the technical, medical, and clinical methodological 
expertise that you possess that is necessary for the design, operation 
and maintenance for the CRC Facility.

iii. Describe how you would evaluate the overall performance of the CRC 
Facility at each stage of its development.

iv. Describe your experience with meeting planning.

4. Personnel

Provide an assessment of the number and mix of personnel required to 
create and operate the CRC Facility and the approximate level of effort 
required, broken down by its major components.

This Request for Information is for 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 the responses nor otherwise pay for the preparation of any 
information submitted or the Government's use of such information. 
Respondents will not be notified of the Government's evaluation of the 
information received.  Should a proposed solicitation 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 indicated.

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

Responses should be identified with RFI No. NS-03-006 and are due by 
March 3, 2003. Please submit three (3) copies of your response to:

Desiree Wheeler
Contract Specialist
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard, Room 3282
Besthesda, MD  20892-9531
(for express mail/courier, use: Rockville, MD  20852)

Email responses will also be accepted at: 

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