USA – FDA issues new draft guidance on data monitoring committees

The US Food and Drug Administration (FDA) on Monday issued a new draft guidance advising certain product sponsors to establish data monitoring committees (DMCs) to ensure that safety signals are detected early. In the past, DMCs were typically seen in clinical trials for serious diseases with “significant morbidity or mortality,” though the agency said that has changed in recent years and that new guidance is needed to advise sponsors on their proper use.

The draft guidance is meant to help clinical trial sponsors figure out when DMCs may be needed and applies to sponsors responsible for managing clinical trials and may potentially apply to third parties who are delegated the task of trial management. The guidance will replace the agency’s 2006 final guidance Establishment and Operation of Clinical Trial Data Monitoring Committees when finalized.

DMCs are sometimes called data and safety monitoring board (DSMB), data and safety monitoring committee (DSMC), and independent data monitoring committee (IDMC). As FDA notes, they’ve been in use since the 1960s and are used by drug sponsors to monitor clinical trial procedures and practices independently, evaluate early efficacy data, and determine if there are safety concerns that should be addressed…