Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Sites for the NINDS Stroke Trials Network (U10)

Notice Number: NOT-NS-13-007

Release Date: February 1, 2013
Estimated Publication Date of Announcement: March 1, 2013
First Estimated Application Due Date: May 15, 2013
Earliest Estimated Award Date: September 30, 2013
Earliest Estimated Start Date: September 30, 2013

NOT-NS-13-008
NOT-NS-13-009

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS), intends to issue a Funding Opportunity Announcement (FOA) to solicit applications for Clinical Sites for the NINDS Stroke Trials Network (U10) . The goal of this initiative is to harness multidisciplinary stroke expertise to work together in an efficient manner to conduct exploratory NINDS-sponsored phase 2 clinical trials for the treatment of stroke with the goal to quickly move potential treatments into larger, confirmatory phase 3 trials. The initiative will provide support to develop, promote and conduct high quality, multi-site clinical trials in stroke focused on key interventions in prevention, treatment, and recovery with the objective to have a balanced portfolio between all three approaches. Exploratory phase 2 and confirmatory phase 3 clinical trials, as well as biomarker-validation studies that are immediately preparatory to trials, will be coordinated through separate Data and Clinical Coordinating Centers (DCC and CCC). Efficiency will be encouraged through the use of master trial agreements and a central IRB. Leaders drawn from both the clinical and basic stroke science communities at the sites will contribute to the development of network clinical trial applications for peer review, as well as planning for execution of applications coming from outside of the network, including trials that result from a Collaborative Research and Development Agreement (CRADA) between the NINDS and an Industry partner. The Network will also be uniquely poised to rapidly collaborate with other existing networks, such as the NINDS Neurological Treatment Trials Network (NETT), or International Consortia to conduct larger, definitive trials of promising interventions for the treatment of stroke. See http://www.ninds.nih.gov/find_people/ninds/OSPP/Stroke-Research-Priorities-Meeting-2012.htm for a description of the Stroke Priorities for this network.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and competitive research programs.

The FOA is expected to be published in Spring 2013 with an expected application due date in May 2013.

This FOA will utilize the U10 activity code. Details of the planned FOA are provided below.

The NINDS Stroke Trials Network will utilize Cooperative Agreements (U10) to support clinical recruiting sites in the Stroke Trials Network for up to 5 years. Each funded site in the network will have access to stroke patients and have demonstrated their ability to enroll patients into stroke trials. Each site will also have strong collaborative relationships between Vascular Neurology, Emergency Medicine, Interventional Neuroradiology, Neurosurgery, NeuroIntensive care, Neuroimaging, Stroke Rehabilitation, and Pediatric Neurology in order to ensure a commitment to offer every eligible patient the opportunity to participate in a trial conducted through the Network. In addition, network sites will include a stroke research training program. All network sites will be committed to increase the value of clinical research data through an aggressive data sharing plan.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Please direct all inquiries to:

Scott Janis, Ph.D.
Program Director
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
Room 2170, MSC 9525
6001 Executive Blvd.
Bethesda, MD 20892-9525
Telephone: (301) 496-9135
Fax: (301) 410-1080
Email: [email protected]