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.


Resources and Tools

Clinical Research Toolkit

View application resources in the toolkit.

Clinical Trial Definition
Clinical Trial FORMS-E
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

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

    SIREN logoSIREN (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 External logoNeurological 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.