Statistical requirements for a Data Safety Monitoring Board (DSMB)

What are the main committees tasked with overseeing a trial?

This figure indicates the three main committees tasked with overseeing a trial, including the Data Safety Monitoring Board (DSMB).

These roles are distinct and should be filled by 3 separate statisticians. Funding is required for the trial and reporting statisticians, although members of the DSMB are seldom renumerated for investigator-led trials. The trial statistician and reporting statistician are usually members of one of the institutes co-ordinating the trial. The DSMB statistician should be external.

If your trial requires a statistician to sit on a DSMB, ACTA STInG have created a list of potential statisticians with experience of contributing to DSMBs on their Find a Statistician database<hyperlink>.

ACTA-STInG also has a mentoring scheme for statisticians to gain experience in DSMBs.

DSMBs for adaptive trials

By their nature, adaptive trials require a lot more statistical support than a standard non-adaptive trial. In particular, they often require regular statistical analysis and monitoring. In this context it is common to have an analytic team (AT) that conducts the regular pre-specified unblinded analyses for the DSMB, which may involve both blinded and unblinded reports.

At least one member of the AT will attend the closed sessions of the DSMB meetings and present the interim results and evaluations of the decision criteria, indicating whether a threshold has been met for a trial adaptation. The AT may also provide additional ongoing trial information, summaries and analyses to the DSMB at the request of the Chair of the DSMB. However, it is the responsibility of the Chair of the DSMB to communicate concerns over adverse event reports or recommendations for trial adaptations to the Chair of the TSC. Adaptive trials often require more support from the DSMB than a non-adaptive design, such as a greater frequency of  meetings and the ability to understand and interpret complex statistical models and decision criteria.

Members of the AT who are unblinded must be independent of the day-to-day running of the trial. There may also be a Statistical Subcommittee who form part of the Trial Steering Committee. The Statistical Subcommittee may comprise of non-independent and independent members, and must remain blinded to trial results from the repeat interim analyses.

Given the complexity of adaptive trials, it is important to consider the level of statistical support and the roles required when designing and planning such a study.

If your trial requires a statistician to sit on a DSMB, search here to find <hyperlink> a potential DSMB statisticians, including a number who have experience with adaptive trials.
The ACTA-STInG DSMB mentoring scheme for statisticians is also a great way to gain experience in DSMBs for adaptive trials.