Clinical Research

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.

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 

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OGHHD logo

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.

 

NINDS Networks

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Heal logo

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.

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StrokeNet logo

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.

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NeuroNEXT logo

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

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SIREN logo

SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network)
Clinical trials in neurologic, heart, lung, blood, and traumatic emergencies.
Contact: Jeremy Brown, M.D.

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Neurological Emergencies Treatment Trials (NETT) Network External logo

Neurological Emergencies Treatment Trials (NETT) Network
This network is no longer active. The network ran Phase III trials of acute injuries and illnesses affecting the brain, spinal cord and peripheral nervous system. New applications requesting network support of emergency care trials access SIREN (above).

 

Resources and Tools

Contacts

Funding Opportunities 

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

SIREN Funding Opportunities

StrokeNet Funding Opportunities

 

 

Related Topics 

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

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Form Approved OMB# 0925-0648 Exp. Date 06/2024