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 NINDS Office of Clinical Research 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 web site.

Mission

Prevention and better treatments for neurological diseases through clinical research.  The Office of Clinical Research (OCR) fosters clinical research that translates Neuroscience discoveries into prevention and treatment of neurological disorders.

1. To promote clinical research leading to improved disease diagnosis, prevention, palliation, and therapy, including epidemiological and natural history studies,  clinical trials, and research into comparative effectiveness or community implementation of existing treatment strategies.
2. To identify promising clinical research strategies in collaboration with extramural and NIH scientists.
3. To provide expertise to the conception, design, and implementation of clinical research to NINDS and investigators and to promote innovations in biostatistical and clinical research methodology.
4. To protect the privacy and safety of research participants and to promote the scientific integrity of research data.
5. To oversee the appropriate use of clinical research funding.
6. To stimulate partnerships and collaboration between academic investigators, foundations, patient groups, industry, NIH, and other Federal agencies.
7. To foster opportunities to improve global neurological health through clinical research.

Funding Initiatives

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

Personnel

Scientific Staff	Research Area
Petra Kaufmann, MD, MS Associate Director for Clinical Research
Minal Bhanushali, MD Clinical Research Fellow
Ken Cheung, PhD Biostatistician	Dose and Selection Design Methodology in Clinical Trials; Biostatistics
Robin Conwit, MD Program Director	NETT, Neurologic Intervention Studies, ALS, Diabetic Neuropathy, Emergency Research
Janice Cordell, RN, MPH Clinical Research Project Manager	Clinical Trials and Epidemiological Studies in Stroke, Epilepsy, Autism
Crina Frincu, PhD Health Program Specialist	NeuroNEXT, Clinical Research Liaison
Wendy Galpern, MD, PhD Program Director	Clinical Trials and Epidemiology Studies in Parkinson’s Disease, Huntington’s Disease, Ataxias; Experimental Therapeutics
Peter Gilbert, ScM Clinical Research Project Manager	Design, Monitoring and Analysis of Clinical Trials; Exploratory Clinical Trials; Biostatistics
Deborah Hirtz, MD Program Director	Pediatric Neurology, Comparative Effectiveness Research, Global Health
Scott Janis, PhD Clinical Research Project Manager	SPOTRIAS, NETT, Clinical Research in Acute Ischemic and Hemorrhagic Stroke and Traumatic Brain Injury
Elizabeth McNeil, MD, MS Program Director	NeuroNEXT, Epidemiology, Pediatric Neurology and Neuro-oncology
Martin Mendoza,PhD Health Program Specialist	Population Tracking
Claudia Moy, PhD, MPH Clinical Research Project Manager	NeuroNEXT, NET-PD, Epidemiology, Ancillary Studies in Clinical Trials, Ethical Issues in Clinical Research, Training
Joanne Odenkirchen, MPH Clinical Research Project Manager	Regulatory and Ethical Issues in Clinical Research, Common Data Elements, Community and International Health Research
Louise Ritz, MBA Clinical Research Program Manager	Clinical Trials Fiscal Management, Safety Monitoring, ClinicalTrials.gov Coordination
Jamie Roberts, MA, CCRP Clinical Trials Specialist	Patient Recruitment and Retention, Site Selection, Resources
Salina Waddy, MD Program Director	Health Disparities, Minority Health

Workshops and Summaries

NEXT: Neuroscience Clinical Trials Network

Hands-On Clinical Trials Workshop for Principal Investigators and Coordinators, July 25-26, 2006

Emergency Neurologic Clinical Trials Network 2004, March 17-18, 2004

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