Clinical Research Overview

Promoting clinical research is a major priority for NINDS. In doing so, NINDS expects research funded by the Institute to meet high standards of scientific rigor in study design and execution and vigilance in the protection of human subjects. Therefore, the conduct of such research is subject to a number of policy and oversight requirements. The clinical trials group at NINDS provides support for all NINDS extramurally-funded clinical trials, consultation in the development of clinical trial applications, in monitoring the progress of the trials, participating in the ongoing management, and ensuring the safety of trial participants.

Program Directors throughout the extramural research program oversee and manage clinical trials; investigators are encouraged to contact the program director who is responsible for the disease of interest. Investigators are advised to meet with NINDS staff prior to the submission of an application in order to determine the relevance of the proposed research to the NINDS strategic plan and its potential for translating discoveries to clinical interventions.

This web site contains NINDS contact information, links to Federal policy statements, links to a number of documents developed by NINDS to assist investigators in meeting NINDS and Federal requirements and in conducting clinical research of the highest quality. Information on the application process, pilot studies, planning grant, definitive/phase III clinical trials, NINDS policies, and guidelines for the study design, protocol outline, and monitoring are found in this website.