The mission of the NINDS Division of Clinical Research is to provide oversight for clinical trials to test the safety and efficacy of innovative treatments of neurological disorders and stroke, epidemiological studies of natural history, biomarker studies, and studies designed to elucidate the causes of neurological disorders. DCR also develops new clinical science initiatives, ensures the proper level of patient safety monitoring, maintains the scientific integrity of clinical trials, and provides expertise in statistics and clinical trial design to the Institute and to clinical investigators.
Investigators are encouraged to contact the program director who is responsible for the disease of interest. View a list of NINDS program directors by category.
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Policy for Submitting Applications Proposing Clinical Trials
- Notice of NINDS Policy for Submission of Applications and Participation in PA-18-345 "NIH Research Project Grant (Parent R01) - Clinical Trial Required". NINDS Only accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 [NOT-NS-18-011]
- Notice of NINDS Policy for Submission of Applications Containing Clinical Trials [NOT-NS-18-054]
NINDS Office of Global Health and Health Disparities
Within the Division of Clinical Research, the office of Global Health and Health Disparities (OGHHD) leads the coordination and development of programs and initiatives that foster global research and research on health disparities in neurological disorders and stroke.
Contact: Richard T. Benson, M.D., Ph.D.
Early Phase Pain Investigation Clinical Network (EPPIC-Net)
Early phase clinical trials of highly meritorious, non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need.
Contact: Barbara I. Karp, M.D.
Stroke Trials Network (NIH StrokeNet)
Phase III clinical trials as well as early phase trials and biomarker studies preparatory to phase III clinical trials in stroke prevention, treatment and recovery.
Contact: Scott Janis, Ph.D.
Early phase clinical trials and biomarker studies preparatory to phase III clinical trials in neurological disorders.
Contact: Sophie Cho, M.D.
SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network)
Clinical trials in neurologic, heart, lung, blood, and traumatic emergencies.
Contact: Jeremy Brown, M.D.
Resources and Tools
Clinton B. Wright, M.D., M.S.
Director, Division of Clinical Research
Clinical Trials in Translational Research
Comparative Effectiveness Research (CER)
NINDS Efficacy Clinical Trials (U01)
NINDS Exploratory Clinical Trials (U01)
NINDS Clinical Research Funding Opportunities
NeuroNEXT Funding Opportunities
StrokeNet Funding Opportunities
Clinical Research Toolkit
View application resources in the toolkit
Clinical Trial Definition
Clinical Trial FORMS-E (use on or before May 24, 2020)
Clinical Trial FORMS-F (use on or after May 25, 2020)
Certificates of Confidentiality
Single IRB Policy
NINDS Guidelines for Data and Safety Monitoring in Clinical Trials
Guidelines for monitoring data and safety from ongoing clinical trials. Responsibilities, membership, and reporting are included.
NINDS Common Data Elements (CDE) Project
Information for NINDS-awardees in the use of CDEs in clinical trials and exploratory trials.
Archived Clinical Research Datasets
Instructions for NINDS awardees on how to submit study results and for the general public on how to request datasets.
NIH Data Sharing Policy
NIH data sharing regulations, policy and implementation guidance.
Incremental Funding of Large Multicenter Studies
This document provides the NINDS guidelines for incremental funding of large multicenter studies and should be used as a reference for program and grants management staff to discuss the funding of large multicenter studies.
Privacy Protection: Certificates of Confidentiality
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure.
Recruitment & Retention Planning: Getting Started
A realistic, targeted strategic recruitment and retention plan, adequately resourced, implemented and adjusted as needed, will have a significant impact on recruitment and retention, ensuring that your clinical trial can complete on time and have the intended impact.