Clinical Research

Program Description

NINDS Division of Clinical Research (DCR) 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

The mission of the NINDS Office of Clinical Research is:

  • 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 the 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.
  • 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.

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.

Resources

Common Data Elements, Data Sharing & Archiving

New Clinical Trials Requirements for Grants and Contracts
Includes new clinical trial definition, new FORMS-E series, and Application Guide

Guidelines for Data and Safety Monitoring in Clinical Trials

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 (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

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


 

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


 

SIREN logoSIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network)
This network will focus on supporting clinical trials aimed at improving the outcomes of patients with neurologic, heart, lung, blood, and traumatic emergencies.

 

StrokeNet logoStroke 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.