Data and safety monitoring in clinical research: a National Institute of Neurologic Disorders and Stroke perspective.
The National Institute of Neurologic Disorders and Stroke supports a broad spectrum of research in the diagnosis and treatment of neurologic disease. Emergency medicine is increasingly involved in clinical research for patients with neurologic emergencies. Independent data and safety monitoring are critical components of clinical trials to ensure the protection of patients and the scientific integrity of the research. We review National Institute of Neurologic Disorders and Stroke principles of data and safety monitoring and provide examples to illustrate key concepts.
Conwit
Robin A
RA
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Neuroscience Center, Bethesda, MD 20850, USA. conwitr@ninds.nih.gov
Hart
Robert G
RG
Moy
Claudia S
CS
Marler
John R
JR
D001741:Black or African American; D026661:Clinical Trials Data Monitoring Committees / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards; D016894:Endarterectomy, Carotid; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D009316:National Institutes of Health (U.S.); D018696:Neuroprotective Agents / Q000009:adverse effects; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D020521:Stroke / Q000208:ethnology / Q000517:prevention & control; D013923:Thromboembolism / Q000139:chemically induced; D000077236:Topiramate; D014481:United States
D018696:Neuroprotective Agents; D010975:Platelet Aggregation Inhibitors; D000077236:Topiramate; D005632:Fructose