Notice of Intent to Publish a Funding Opportunity Announcement for Data Coordinating Center for the NINDS Stroke Trials Network (U01)
Date: February 1, 2013
Estimated Publication Date of Announcement: June 1, 2013
First Estimated Application Due Date: September 1, 2013
Earliest Estimated Award Date: April 1, 2014
Earliest Estimated Start Date: April 1, 2014
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 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 September 2013.
This FOA will utilize the U01 activity code. Details of the
planned FOA are provided below.
The NINDS Stroke Trials Network will utilize Cooperative Agreements (U01) to support a Data Coordinating Center in the Stroke Trials Network for up to 5 years. The Statistical and Data Coordinating Center (DCC) will support protocol data management, data quality control (including data monitoring), and undertake interim monitoring, analyses and reporting for the Clinical Coordinating Center, NINDS, and Data and Safety Monitoring Boards (DSMBs). The DCC will also initiate and coordinate activities to promote standardization of data elements using the NINDS Stroke common data elements and support an aggressive sharing policy for de-identified data.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Scott Janis, Ph.D.
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