Notice of Intent to Publish a Request for Applications for a Clinical Coordinating Center to establish the Network for Excellence in Neuroscience Clinical Trials (NEXT-CCC) (U01)

Notice Number: NOT-NS-10-026

Release Date: September 7, 2010

NOT-NS-10-025 and NOT-NS-10-027

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) intends to issue a Request for Applications (RFA) for U01 grant applications in support of a clinical coordinating center (CCC) to establish the Network for Excellence in Neuroscience Clinical Trials (NEXT). This clinical research network will develop and conduct multiple early stage clinical trials and research studies to enable the efficient testing of the most promising therapies from academia or industry. Examples include proof-of concept trials and preparatory studies aimed at validating biomarkers and clinical outcomes in neurological disorders including pediatric patients and rare diseases. The network will provide a robust, standardized, and accessible infrastructure to rapidly develop protocols and will coordinate a cadre of specialist investigators to implement studies efficiently.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Two companion RFAs will be concomitantly released, requesting U10 grant applications in support of clinical research sites [NOT-NS-10-025] and U01 grant applications in support of a data coordinating center (DCC) [NOT-NS-10-027]. Note that the current planned RFAs will establish the collaborating Coordinating Centers and Clinical Research Sites. Separate FOAs may be published in the future to invite applications for Phase II clinical trials and preparatory research studies that will be conducted within the network.

The RFA is expected to be published in fall of 2010 with an expected receipt date in winter of 2011.

The Clinical Coordinating Center RFA will utilize the U01 mechanism activity code. Details of the planned Funding Opportunity Announcement (FOA) are provided below.

This Notice encourages investigators with expertise in clinical trials to consider applying for this new RFA.

Successful applicants for the Clinical Coordinating Center (U01) will have a proven track record in successful clinical and project management of neuroscience trials including, but not limited to:

• protocol development
• adherence to GCP and all other regulatory requirements
• efficient contracting and IRB procedures
• development and implementation of recruitment plans, and safety monitoring and reporting plans

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Please direct all inquiries to:

Petra Kaufmann, MD
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Blvd., Room 2116
Bethesda, MD 20892-9520
Express/Courier: Rockville, MD 20852
Telephone: (301) 496-9135
Fax: (301) 401-5301
Email: Petra.Kaufman@nih.gov
http://www.ninds.nih.gov/