Janet Wittes, PhD and Scott Evans, PhD will present “A Primer on Data Safety Monitoring Boards” as part of the Biostatistics Center's GW University Seminar series on clinical trials. The seminar will be from 11am-1pm, followed by lunch at 1pm. To attend the post-seminar lunch, please RSVP by Thursday, May 29 via the following form: https://forms.gle/B7SoujmLz93iHJCF7.

Seminar Abstract: Attached to many randomized controlled trials is a group of experts who assess ongoing data from the trial. The group, called a Data and Safety Monitoring Board (DSMB) – or some variant of that name - aims to protect trial participants and to ensure that the trial does not continue longer than necessary to answer the questions it set out to address. Ideally, the Board operates independently of the organizations funding and running the trial; it has unfettered access to the data it needs to operate efficiently, scientifically, and ethically; and it, as well as the other units involved in the trial, understands and respects its role. Each of us has sat on many DSMBs, both for government agencies and for industry. Our introduction to these committees began decades ago. Thus, we have seen the evolution of practice emerge as trialists have become more experienced in how best to create and operate DSMBs.

The session starts with a brief history of DSMBs. We describe the ways DSMBs should run, and we outline the structure of the reports they should see in order to fulfill their responsibilities effectively.

We then discuss some all too frequent deviations from the ideal that lead to problems in the DSMB’s ability to evaluate ongoing data reliably. All too often the independence of the DSMB is somewhat compromised. Many groups reporting to DSMBs present uninterpretable summaries of data. Unfortunately, the cadre of people with sufficient experience to serve on and report to DSMBs is small.

The final section of the presentation provides an optimistic view of the future. We offer suggestions that, if adopted, should increase the likelihood that future DSMBs will usually operate more closely to the ideal. Finally, for those interested in joining a DSMB or in reporting to DSMBs, we present case studies illustrating important lessons. We end with some proposed actions for you to take individually and for clinical trialists to adopt collectively in an effort to improve the quality of DSMBs.

We hope to encourage a lively question and answer section, so if you have burning (or even not-so-burning questions), bring them to us.