Remits, roles and working models for trial steering committees and data monitoring committees in studies evaluating diagnostic tests: a survey of current practice

Background All clinical trials that involve the prospective study of patients need some form of independent monitoring. For RCTs of therapeutic interventions, UK public funders of research – including the MRC – require an independent trial steering committee (TSC) to oversee management and finances, and a data monitoring committee (DMC) to oversee study progress and accumulating study data. This fully independent TSC/DMC model may not always be necessary for trials of tests. To address the deficit in guidance regarding oversight arrangements, a project funded by the MRC Midlands Hub for Trials Methodology Research is being undertaken to investigate how DMCs and TSCs should operate.