NINDS PILOT CLINICAL TRIALS NETWORK

RELEASE DATE:  May 5, 2003

NOTICE:  NOT-NS-03-008

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) is 
seeking information that may be used to help develop specifications for a 
network for pilot clinical trials and those organizations that might be 
capabilities to conduct such an effort.  NINDS is seeking input about the 
technical expertise required and available to create and operate an efficient 
network, as well as input into its specific structure.

Background

Recent progress in neuroscience has led to an explosion in potential 
pharmacological interventions for neurological diseases that require testing 
in clinical trials.  NINDS is supporting initiatives for drug screening and 
pre-clinical testing (http://grants.nih.gov/grants/guide/pa-files/
PAR-02-139.html).  However, many interventions may never reach early phase 
clinical trials.  There are several barriers to entry for pilot clinical 
trials, including issues of competing interventions, infrastructure and funding, 
access to patient populations, lack of experienced clinical investigators, 
and inadequate communication between pre-clinical and clinical researchers.  
The goal of this project is to ensure that potential treatments are tested in 
pilot clinical trials in a timely and efficient way by developing a network 
of sites and a coordinating center that could implement trials for different 
neurological diseases.  The trials conducted by this network would be studies 
that are needed to determine if further clinical testing of the intervention 
is warranted.  The proposed network will be a resource for investigators to 
test promising new agents that result from pre-clinical translational 
research efforts. 

The overall objective of the network is to facilitate the timely transition 
from pre-clinical to clinical studies.  Within the network, hundreds of 
academic-based and practice-based centers would be pre-qualified, based on 
simple criteria, to participate in pilot trials for one or more diseases.  
The goal is to have broad participation and representation of different 
populations and diseases to limit the barriers for sites to enter the 
network.  New sites would be invited to apply to be added to the network at 
regular intervals.  Sites would be maintained in the network at minimal cost, 
then compete to participate in specific fully funded studies as the need 
arises.  Each year, the network will potentially start two or more pilot 
studies.  There will be a single coordinating center that will work with 
investigators to develop protocols, consent documents and case report forms, 
facilitate compliance with regulatory requirements, train and monitor study 
sites, and perform data management and analysis, and coordinate all aspects 
of the network.  It is anticipated that the network will perform studies in 
disease areas in which few if any previous clinical trials have been 
performed.  Thus, substantial flexibility and intellectual leadership – 
clinical and statistical – will be required on the part of the coordinating 
center.  The selection of particular interventions for study will be 
performed by a steering committee comprised of NIH staff and scientists 
independent of the centers in the network.  Participation in the network will 
not replace existing grants or contracts to perform clinical studies, nor 
should it discourage independent investigators or existing networks or 
cooperative groups from applying for funding.  The network will expedite 
clinical testing for select, high priority agents and provide clinical trials 
infrastructure where needed.

The major aims of the network are:

1.    to facilitate the transfer of pre-clinical research results to clinical 
trials.
2.    to minimize the cost of the infrastructure by building a network for 
several disease areas.
3.    to make study of rare neurological diseases economically feasible
4.    to expedite recruitment of subjects.
5.    to involve a wide spectrum of investigators .
6.    to recruit a broad range of participants, particularly minorities.
7.    to make participation in NINDS clinical research more accessible to 
patients.

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

Information Requested

Information in the areas listed below will aid in the design of a 
solicitation to establish and operate the network.  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 network

a.    What are the major essential components of the network?  What expertise, 
capabilities, and levels of effort are required for each of the network 
centers and for the coordinating center?
b.    Should the network included centers capable of performing phase I studies 
in healthy subjects?
c.    What are the barriers to participation of neurological disease treatment 
centers in this endeavor?
d.    What steps (or phases) are necessary for initiation of the network?  What 
is the proposed timeline?
e.    What should the criteria be for selecting treatments to be studied in 
this network and how should this selection process be organized?
f.    How can outreach and recruitment of children, women, and minority 
participants be implemented?
g.    How can outreach and recruitment of uncommon disease populations be 
implemented?
h.    What low-cost effort would sustain the capability of centers in the 
network to compete for the opportunity to participate in studies when the 
opportunity arises?
i.    Only a small fraction of centers would ever participate in any trials.  
What benefits would there be for the network centers that do not successfully 
compete to participate in trials sponsored by NINDS?  

2.    Subcontract Award and Management

The pilot trial network may involve hundreds of investigators funded through 
small 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 network 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 network.

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

b.    Describe the technical, medical, and clinical methodological expertise 
that you possess that is necessary for the design, operation, and maintenance 
for the network.

c.    Describe how you would evaluate the overall performance of the network at 
each stage of its development.

d.    Describe your resources for organizing training and planning sessions for 
the investigators.

4.    Personnel

For the following, assume that at any time several hundred network centers 
would be qualified in one or more disease areas and that one or two 30-100 
patient early to middle development studies would be started per year, each 
study to last 2 years or less.  The number of centers to participate would 
vary widely depending on the scarcity of patients.  The costs at each center 
would have to vary based on the number of patients they could be expected to 
provide.  

Provide an assessment of the number and mix of personnel required to create 
and operate the network 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 organization.

Responses should be identified with RFI No. NS-03-008 and are due by June 16, 
2003.  Please submit three (3) copies of your response to:

Laurie A. Leonard
Contracting Officer
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard, Room 3282
Bethesda, MD  20892-9531
(for express mail/courier, use: Rockville, MD  20852)

Email responses will also be accepted at:  LL44S@nih.gov 

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