NINDS PILOT THERAPEUTICS NETWORK CLINICAL OPERATIONS CENTER: NPTUNE COC

RELEASE DATE:  April 30, 2004

NOTICE:  NOT-NS-04-013

RFP Available: NIH-NINDS-RFP-04-05 

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

The National Institute of Neurological Disorders and Stroke (NINDS) is seeking 
to form a network to perform pilot clinical trials for neurological diseases.  
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 under a 
single operations center that could implement small scale trials for different 
neurological diseases. The trials conducted by this network would be studies 
that are needed to gain the information about the intervention (such as the 
dose, kinetics, route of administration, safety, and preliminary evidence of 
activity) needed to design a phase III trial. The proposed network will be a 
resource 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, academic-based and 
practice-based centers could be pre-qualified, based on simple criteria, to be 
eligible 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 the network at regular intervals.  The contractor will 
maintain eligible sites that may then compete to participate in specific, fully 
funded studies as the need arises.  Each year, the network will potentially run 
two (2) or more concurrent pilot studies.  There will be a single operations 
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, perform data management and analysis, and coordinate 
all aspects of the network.  It is anticipated that the pilot studies will 
involve disease areas with little or no previous experience in clinical trials, 
requiring intellectual leadership – clinical and statistical – on the part of 
the operating center.  The selection of particular interventions for study will 
be performed by an external advisory committee comprised of NIH staff and 
scientists independent of the centers in the network.  The network will expedite 
clinical testing for select, high priority agents and provide clinical trials 
infrastructure where needed.  

It is anticipated that one performance based type contract will be made for a 
period of five (5) years in October, 2004.  This is not a Request for Proposals 
(RFP).  THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY.  Request for 
Proposal (RFP) No. NIH-NINDS-04-05 will be available electronically and may be 
accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) 
or through the NINDS website at the following URL address: 
(http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm) 
15 or more calendar days after the issuance of this synopsis.  OFFERORS ARE 
RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION 
AMENDMENTS THAT MAY BE ISSUED.  NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS 
WILL BE PROVIDED.  All responsible sources may submit a proposal, which shall 
be considered by the agency.  Refer to number note 26. *****

INQUIRIES

Inquiries may be directed to:

Helene Braun, Contract Specialist
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3287
6001 Executive Boulevard, MSC 9531
Bethesda, MD  20892-9531
Tel:  (301) 496-1813
Fax:  (301) 402-4225
Email:  hb106s@NIH.GOV

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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