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Notice of Special Interest (NOSI): Platform Trials of Thrombectomy in Acute Stroke Treatment

Notice of Special Interest
Wednesday, August 5, 2020
Thursday, July 15, 2021
UG3/UH3
NOT-NS-20-095

Funding Opportunity Purpose

Notice Special Interest NOSI): Platform Trials Thrombectomy Acute Stroke Treatment Notice Number: NOT-NS-20-095 Key Dates Release Date: August 5, 20 First Available Due Date: October 14, 2020 Expiration Date: July 15, 2021 Related Announcements PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS issuing Notice Special Interest applications establish master protocol conduct platform trials treatments ischemic stroke due large vessel occlusion. Master protocols should incorporate advanced clinical trial methodologies such as, not limited to, Bayesian modeling, response adaptive randomization, shared controls, the ability treatment arms enter, leave, be combined. Master protocols must designed allow future addition trial questions. Strong representation expertise the neurology, neurosurgery, interventional communities required such multi-disciplinary approach will expected applicants. Research Objectives Recent pivotal interventional trials patients ischemic stroke due large vessel occlusion shown mechanical thrombectomy be highly beneficial certain groups patients to 24 hours after last known well. However, questions remain the potential benefit harm thrombectomy specific subgroups patients certain ischemic stroke phenotypes. Also interest considerations such pre-hospital care peri-procedural management strategies. Further, success mechanical thrombectomy raises possibility a new era neuroprotection patients large vessel ischemic stroke. Promising neuroprotectants failed trials predated successful reperfusion, well newer agents have potential remain untested, ripe consideration this new environment. NINDS interested master protocols enable platform trials answer above questions using seamless rolling approach. Trials further refine patient groups do do benefit mechanical thrombectomy, using management approaches, also open door testing neuroprotectant strategies an efficient, timely, cost-effective manner. Clinical study protocols consist acute short-term procedures are deemed Non-Significant Risk NSR) an Institutional Review Board IRB), Significant Risk SR) studies require Investigational Device Exemption IDE) the FDA. Evidence contact appropriate U.S. regulatory bodies e.g., IRB NSR studies and/or FDA the form either Pre-Submission meeting IDE submission SR studies recommended. Applicants must the resources ability do work without critically impacting high-priority, on-going NINDS research programs. Investigators planning submit application response the NOSI strongly encouraged contact program officer listed below discuss proposed project. Application Submission Information notice applies due dates or after October 14, 2020 subsequent receipt dates through July 14, 2021.  Applications this initiative must submitted using following funding opportunity announcement FOA) any reissues these announcement through expiration date this notice: PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-NS-20-095” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications non-responsive terms this NOSI be be considered the NOSI initiative. Applications nonresponsive terms this NOSI will not considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)

PAR
Wednesday, July 29, 2020
Monday, July 24, 2023
UG3/UH3
PAR-20-285

Funding Opportunity Purpose

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional)

PAR
Tuesday, January 9, 2018
Clinical Trials Research
Tuesday, April 6, 2021
U44
PAR-18-563

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.