Tag: DSMBs

  • Data Monitoring Committees: Observations & Issues – Part I

    Data Monitoring Committees: Observations & Issues – Part I

    Data Safety Management Boards (DSMBs), also known as Data Monitoring Committees (DMCs), are a complex issue. They are described in two similar documents, one from the FDA from 2006 and the other from the EMA. Another interesting document on these committees has been put out by the UK National Health Service. This posting and the…