NOT-NS-14-043: Notice of Clarification of NINDS Policy for the Submission of Multi-site Clinical Trials in Stroke Treatment, Recovery, or Prevention

Notice of Clarification of NINDS Policy for the Submission of Multi-site Clinical Trials in Stroke Treatment, Recovery, or Prevention

Notice Number: NOT-NS-14-043

Key Dates
Release Date: August 26, 2014

Related Announcements
PAR-14-220
PAR-14-252
PAR-14-253

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

NINDS has established the NIH Stroke Clinical Trials Research Network (NIH StrokeNet) to facilitate rapid initiation and efficient implementation of NINDS-funded stroke trials. The network is specifically designed to harness multidisciplinary stroke expertise to conduct exploratory (i.e., phase 1 and 2) and confirmatory (i.e., phase 3) clinical trials for acute stroke treatment, stroke recovery and rehabilitation, or primary or secondary stroke prevention; these may include so-called pragmatic trials performed in large numbers of patients with minimal alteration from clinical practice and low per-patient costs. Exploratory clinical trials must include a clearly defined go/no-go pathway toward advancement to a future phase 3 trial. In addition, the network will support studies to validate biomarkers with demonstrated promise to inform phase 2 clinical trials.

While additional sites outside of the StrokeNet network of Regional Coordinating Centers may be required, NINDS expects that any phase 3 trial proposed to and subsequently conducted within the network will utilize most or all of the Regional Coordinating Centers. Exploratory trials and biomarker validation studies are expected to use at least 5 Regional Coordinating Centers and should be feasible within the network with the addition of relatively few non-StrokeNet sites (note that the applicant institution, if not a StrokeNet site, may be included as a performance site in the study). The final number of sites needed for a proposed study will be determined following a feasibility assessment by the StrokeNet.
NINDS has issued three companion Funding Opportunity Announcements (PAR-14-220, PAR-14-252, PAR-14-253) to which all relevant applications should be submitted. Only in exceptional circumstances will NINDS consider funding multi-site stroke clinical trials outside of this program.

Individuals interested in applying to NINDS for funding for a clinical trial in stroke treatment, recovery, or prevention are strongly advised to contact NINDS at least 3 months in advance of a planned submission to determine the appropriate funding mechanism for their application.

Inquiries

Please direct all inquiries to:

Claudia Scala Moy, PhD
National Institute of Neurological Disorders & Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]