Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members

Abstract

Regulatory authorities in the US and EU recommend that pharmaceutical companies employ data monitoring committees (DMCs) to protect the safety of patients taking part in large randomized trials involving diseases with high morbidity or mortality and have provided guidance as to how such committees should be used. This article, whose authors have considerable experience in DMC membership, reviews the applicability of guidance to sponsors after 5 years and suggests that regulatory support for DMC members would be valuable. Advice is offered to members, often very experienced clinicians but inexperienced in pharmaceutical data review, as to how standard DMC data packages should be reviewed, which aspects of trial validity should be addressed, and how communication with the trial sponsor should be handled. It is suggested that DMCs could be supported by regulatory authorities in managing ethical and legal dilemmas to make DMC membership less exposed and more inviting.