Independent Data Monitoring Committees (IDMCs) have become an essential part of drug development. Not every clinical trial needs to have an IDMC, but the number of trials that utilise an IDMC is growing; moreover, some trials may have more than one type of data review committee. For example, a single trial might have not only an IDMC but also an Endpoint Adjudication Committee (EAC), a Diagnosis Review Committee and other committees simultaneously. Different committees have different goals, responsibilities and compositions. In this paper we explore the critically important topic of IDMC member selection.

Establishing an IDMC is the responsibility of the clinical trial sponsor. However, the sponsor may delegate this task partly or entirely to a vendor or contract research organisation (CRO). The responsibilities of an IDMC include monitoring safety of trial participants and validity of trial data, as well as major decisions such as recommending to the sponsor whether to continue, stop, or modify the trial. Therefore, selection of appropriate IDMC members involves a number of critically important criteria. IDMC members should collectively have a combination of medical, statistical and ethical expertise, past or present experience with clinical trials and serving on other IDMCs, independence from potential conflicts of interest (COI) and certain personal characteristics. Other factors to be considered when establishing the IDMC and selecting its members include the number of members, geographical representation and the specialties and qualifications of those members. In addition to these general and universal criteria, there may be trial-specific criteria to consider during the selection process.