When does my clinical trial require a Data and Safety Monitoring Board (DSMB)?
A DSMB is generally required for Phase III clinical trials. For earlier medication trials (Phase I or II) and some behavioral clinical trials, a DSMB may be appropriate if the study has multiple clinical sites, is blinded, tests a high-risk intervention, or is conducted in vulnerable populations. Generally, Phase III trials involve larger numbers of subjects, but size is not a specific criterion for this designation. NIDA provides guidelines for establishing and operating a DSMB at: http://www.drugabuse.gov/Funding/GuideDSMB.html.
