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 

 

NINDS Networks

 

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.

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.