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Office of Clinical Research


NINDS Office of Clinical Research (OCR) exists to provide support for all NINDS extramurally-funded clinical studies and trials, including:

  • Consultation in the development of clinical research applications
  • Monitoring the progress of clinical research studies and trials
  • Participating in the ongoing management of clinical research projects
  • Ensuring the safety of study participants

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 as well as vigilance in the protection of human subjects. Therefore, the conduct of such research is subject to a number of policy and oversight requirements, details of which may be found below..

Program Directors throughout the extramural research program oversee and manage clinical studies and trials. Investigators are encouraged to contact the program director who is responsible for the disease of interest (see Personnel). Investigators are also 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 mission and priorities.




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.

Personnel

Scientific StaffResearch Area
Elizabeth McNeil, MD, MS
Acting Associate Director 
Clinical Research
NeuroNEXT, Epidemiology, Pediatric Neurology and Neuro-oncology

Robin Conwit, MD
Program Director

NETT, Neurologic Intervention Studies, ALS, Myasthenia Gravis, Neuropathy, Emergency Research
Janice Cordell, RN, MPH
Clinical Research Project Manager
NeuroNEXT, Clinical Trials and Epidemiological Studies, Safety Monitoring
Crina Frincu, PhD
Health Program Specialist

NeuroNEXT, Clinical Research Liaison

Wendy Galpern, MD, PhD
Program Director
Clinical Trials and Clinical Research in Movement Disorders including Parkinson’s disease, Huntington’s disease, ataxias, PSP/CBD, tremor, dystonia; Experimental Therapeutics
Peter Gilbert, ScM
Clinical Research Project Manager
Design, Monitoring and Analysis of Clinical Trials; Exploratory Clinical Trials; Biostatistics
Marie Gill
Health Program Specialist
Gender and Minority Inclusion Monitoring
Deborah Hirtz, MD
Program Director
Pediatric Neurology, Comparative Effectiveness Research, Implementation Research, Global Health
Scott Janis, PhD
Program Director
StrokeNet,  NETT, Clinical Trials in Stroke and Traumatic Brain Injury
Claudia Moy, PhD, MPH
Program Director
StrokeNet, Epidemiology, Patient-centered outcomes; clinical research in stroke and other cerebrovascular disorders
Joanne Odenkirchen, MPH
Clinical Research Project Manager
Regulatory and Ethical Issues in Clinical Research, Common Data Elements, Community and International Health Research, Clinical Trials
Louise Ritz, MBA
Clinical Research Program Manager
Clinical Trials Fiscal Management
Jamie Roberts, MA, CCRP
Clinical Trials Specialist
Subject Recruitment and Retention, Site Selection, Clinical Study Performance Metrics, Research Ethics, Health Communication and Marketing
Joanna Vivalda, RN, MBA, CCRA
Clinical Trials Specialist
StrokeNET, Traumatic Brain Injury, Safety Monitoring, ClinicalTrials.gov liaison, Certificates of Confidentiality coordinator
Salina Waddy, MD
Program Director
Stroke, Health Disparities, Minority Health
Patricia Walicke, MD PhD
Health Science Administrator
NeuroNEXT, Translational Research, Dementia, Neurodegenerative Diseases, Neuroimmunology disorders, Pain

CDEs, Data Sharing & Archiving

NIH Data Sharing Policy: NINDS believes data sharing is essential to expedite the translation of research results into knowledge, products and procedures to improve human health.  

NINDS Common Data Elements Logo NINDS Common Data Elements (CDE) Project
NINDS expects the clinical research it funds to meet the highest standards of scientific rigor yet appreciates the burden that extensive data collection puts on investigators and study participants.

Streamline Your Neuroscience Clinical Research using content standards that enable clinical investigators to systematically collect, analyze, and share data across the research community. NINDS strongly encourages researchers who receive funding from the Institute to ensure their data collection is compatible with these common data elements (CDEs)

Archived Clinical Research Datasets - The data from NINDS-supported clinical trials are an important scientific resource, made available to the wider scientific community, while ensuring that the confidentiality and privacy of study participants are protected.  NINDS requires all investigators seeking access to data from archived NINDS-supported trials to agree to certain terms and conditions. 

NINDS Networks

NETT Logo Neurological Emergencies Treatment Trials (NETT) Network: Phase III trials of acute injuries and illnesses affecting the brain, spinal cord and peripheral nervous system. 

 

NeuroNEXT: Early phase clinical trials and biomarker studies preparatory to phase III clinical trials in neurological disorders.

 

The Stroke 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.

 

Last Modified December 19, 2014