Program Description

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.

View information related to translational research. 

Notice of Special Interest regarding the Availability of Administrative Supplements and Urgent Competitive Revisions for the Establishment and Maintenance of a Research Database for Neurological Manifestations of the SARS-CoV-2 (Notice Number: NOT-NS-20-046)

• Frequently Asked Questions (FAQs) (pdf, 402 kb)

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]

Resources and Tools

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)
Clinical Trials.gov
Certificates of Confidentiality
Single IRB Policy
Protocol Template

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.
Learn more about Data & Safety Monitoring Board (DSMB)

NINDS Common Data Elements (CDE) Project

Information for NINDS-awardees in the use of CDEs in clinical trials and exploratory trials.
Learn more about CDE's

Archived Clinical Research Datasets

Instructions for NINDS awardees on how to submit study results and for the general public on how to request datasets.
Learn more about Data Sharing Policy

NIH Data Sharing Policy

NIH data sharing regulations, policy and implementation guidance.
Learn more about Data Sharing Policy

NINDS Networks

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.

NeuroNEXT
Early phase clinical trials and biomarker studies preparatory to phase III clinical trials in neurological disorders.
Contact: Codrin Lungu, 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.

 

Neurological Emergencies Treatment Trials (NETT) Network
Phase III trials of acute injuries and illnesses affecting the brain, spinal cord and peripheral nervous system. *For new applications requesting network support of emergency care trials see SIREN (above).
Contact: Robin Conwit, M.D.