August 5, 20
PAR-20-285 - NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)
National Institute of Neurological Disorders and Stroke (NINDS)
The NINDS is issuing this Notice of Special Interest in applications to establish a master protocol to conduct platform trials for treatments of ischemic stroke due to large vessel occlusion. Master protocols should incorporate advanced clinical trial methodologies such as, but not limited to, Bayesian modeling, response adaptive randomization, shared controls, and the ability for treatment arms to enter, leave, or be combined. Master protocols must be designed to allow future addition of trial questions. Strong representation of expertise from the neurology, neurosurgery, and interventional communities is required for such a multi-disciplinary approach and will be expected of applicants.
Recent pivotal interventional trials in patients with ischemic stroke due to large vessel occlusion have shown mechanical thrombectomy to be highly beneficial in certain groups of patients up to 24 hours after last known well. However, many questions remain about the potential for benefit or harm of thrombectomy in specific subgroups of patients or certain ischemic stroke phenotypes. Also of interest are considerations such as pre-hospital care and peri-procedural management strategies.
Further, the success of mechanical thrombectomy raises the possibility for a new era in neuroprotection for patients with large vessel ischemic stroke. Promising neuroprotectants that failed in trials that predated successful reperfusion, as well as newer agents that have potential but remain untested, are ripe for consideration in this new environment.
The NINDS is interested in master protocols to enable platform trials that answer the above questions using a seamless rolling approach. Trials that further refine patient groups that do or do not benefit from mechanical thrombectomy, and using which management approaches, will also open the door to testing neuroprotectant strategies in an efficient, timely, and cost-effective manner.
Clinical study protocols may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA. Evidence of contact with appropriate U.S. regulatory bodies e.g., IRB for NSR studies and/or FDA in the form of either Pre-Submission meeting or IDE submission for SR studies is recommended.
Applicants must have the resources and ability to do the work without critically impacting other high-priority, on-going NINDS research programs.
Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officer listed below to discuss the proposed project.
Application and Submission Information
This notice applies to due dates on or after October 14, 2020 and subsequent receipt dates through July 14, 2021.
Applications for this initiative must be submitted using the following funding opportunity announcement (FOA) or any reissues of these announcement through the expiration date of this notice:
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Applications non-responsive to terms of this NOSI will be not be considered for the NOSI initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.