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  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.

Mission

• To initiate and guide the development of phase III clinical trials to test the safety and efficacy of innovative treatments of neurological disorders and stroke.
• To develop new scientific initiatives to stimulate translation of ideas from basic animal research to testing the safety and early indications of efficacy through phases I and II clinical trials.
• To promote epidemiological studies of the natural history and early markers of neurological disorders and stroke, to elucidate the causative path leading to the disorders and to stimulate the search for new treatments and prevention strategies.
• To provide oversight and serve as a resource to the Institute and to the investigators, to ensure proper level of patient safety monitoring and to maintain the scientific integrity of clinical trials.
• To participate in the Institute's efforts to develop evidence-based clinical guidelines for physicians and patients.
• To provide expertise in statistics and clinical trial design to the Institute and to clinical investigators.

Funding Initiatives

• RFAs, PAs and Funding Notices from the Office of Clinical Research

Personnel

 

Jancie Cordell Clinical Research Project Manager jc53a@nih.gov

Brandy Fureman, Ph. D Clinical Research Project Manager furemanb@mail.nih.gov

Peter Gilbert, Sc.M. Clinical Research Project Manager gilbertp@ninds.nih.gov

Scott Janis, Ph.D. Clinical Research Project Manager janiss@ninds.nih.gov

Claudia Moy, Ph.D. Clinical Trials Group Administrative Leader cm384s@nih.gov

Joanne Odenkirchen, M.P.H. Clinical Research Project Manager odenkirj@ninds.nih.gov

Robin Conwit, M.D. Program Director rc296d@nih.gov

Wendy Galpern, MD., Ph.D. Program Director wg71m@nih.gov

Laurie Gutmann, M.D. Program Director lg245o@nih.gov

Deborah Hirtz, M.D. Clinical Trials Group Science Leader dh83f@nih.gov

A. Louise Ritz, M.B.A. Clinical Research Project Manager

Workshops and Summaries

Emergency Neurologic Clinical Trials Network March 17-18, 2004
Stroke Risk Assessment and Future Stroke Primary Prevention Trial: Workshop Summary  January 13 - 14, 2004
Improving the Chain of Recovery for Acute Stroke in Your Community December 12 - 13, 2002
NINDS Stroke Disparities Advisory Panel Meeting November 7 - 8, 2002
NINDS Clinical Research Collaboration Workshop October 7 - 8, 2002
Research on Psychosocial and Behavioral Interventions in Autism: Confronting the Methodological Challenges September 5 - 6, 2002
Optical Imaging Workshop: from Bench to Bedside at the NIH September 7-8, 2000
National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996

Address

Neuroscience Center
Room 2209
6001 Executive Blvd.
Bethesda, MD 20892-9520

Tel 301-496-9135
Fax 301-480-1080

For courier service only, use Rockville, MD 20852