Notice Number: NOT-NS-13-008

Key Dates
Release Date: February 1, 2013
Estimated Publication Date of Announcement: March 1, 2013
First Estimated Application Due Date: June 4, 2013
Earliest Estimated Award Date: September 30, 2013
Earliest Estimated Start Date: September 30, 2013

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

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS), intends to issue a Funding Opportunity Announcement (FOA) to solicit applications a Clinical Coordinating Center in the “NINDS Stroke Trials Network (U01)”. 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 U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The NINDS Stroke Trials Network will utilize Cooperative Agreements (U01) to support a Clinical Coordinating Center in the Stroke Trials Network for up to 5 years. The Clinical Coordinating Center (CCC) provides overall study coordination, working closely with the DCC and the clinical sites. The CCC will coordinate the activities of the SC, develop and implement investigator and staff training programs and meetings, oversee drug acquisition and distribution as needed, work closely with the project-specific lead protocol teams, support project investigators in IND submission and reporting to the Food and Drug Administration (FDA), establish and maintain standardized master trial agreements with the network sites and distribute funding for network trial projects, maintain regulatory documents and coordinate the central IRB process, monitor eligibility of participants, assure compliance with regulations and monitor the informed consent process, prepare blinded reports on adverse events, monitor study execution at sites, support outreach to patients and inclusion of patients in protocol and recruitment plan development, supervise and encourage recruitment, editorial and meeting coordination for manuscript preparation, and development of operational and publication guidelines within the framework outlined by the network CCC FOA. The CCC will also coordinate the development of clinical trial protocols to be submitted to the NINDS for peer review for future execution in the Stroke Trials Network. In addition, the Clinical Coordinating Center will collaborate with the Statistical and Data Management Center in developing and implementing data management procedures. The Clinical Coordinating Center will be responsible for quarterly progress reports to the NINDS, the NINDS-appointed Network Advisory Group, and one or more Data and Safety Monitoring Boards
(DSMBs).

Inquiries

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]