What is the DSMB and Why You Should Know

The Data and Safety Monitoring Board (DSMB) established to monitor COVID-19 vaccines this week announced they were reviewing the clinical trial data submitted by Astra Zeneca for their COVID-19 vaccine. But what is a DSMB, and why is it important for clinical research sites to know?

A Data and Safety Monitoring Board (DSMB) is an independent group of experts that objectively evaluates trial data periodically for integrity and to assure the safety of clinical trial participants. DSMBs must provide the recommendations from their evaluation to  researchers such as those at the National Institutes of Health (NIH) or for industry trials the sponsor (e.g. pharma or device companies). Individual institutes within the NIH have their own policies regarding data and safety monitoring plans and data and safety monitoring boards.

The panel of scientists is independent of both the manufacturers developing a drug or vaccine, as well as the government officials who will approve it.

The NIH requires the establishment of data safety monitoring boards for multi-site clinical trials involving interventions that entail potential risks to participants (generally Phase III clinical trials).

The primary responsibilities of the DSMB are to:

  • periodically review and evaluate the accumulated trial data for participant safety, trial conduct and progress, and, when appropriate, efficacy, and
  • make recommendations concerning the continuation, modification, or termination of the trial

DSMBs have received more public recognition among the general media because of their role in ensuring the safety of the many current COVID vaccine trials. Both AstraZeneca and Johnson & Johnson, two companies working on COVID-19 vaccines, paused clinical trials on the advice of their DSMBs when two patients, one enrolled in each trial, experienced adverse events. After a review of the data, the DSMBs determined that both trials could continue safely. Although the FDA is not required to take the advice of the DSMB, they often do.

It is very important that DSMBs operate independently to maintain objectivity and make unbiased decisions when interpreting data. In some cases, particularly in non-NIH-funded trials, drug developers might establish their own independent committees.

Why this matters to clinical research sites

For NIH-funded studies, regulatory policy has explicitly identified required communications that must occur between DSMBs and Institutional Review Boards (IRBs). The two groups have distinct and complementary roles in ensuring the safety of human subjects in clinical trials.

A DSMB reviews, among other things, the following:

  • Data quality, completeness and timeliness
  • Site adherence to the protocol
  • Performance of individual centers
  • Adequacy of compliance with goals for recruitment and retention, including those related to the participation of women and minorities

The DSMB then provides feedback at regular and defined intervals to researchers and/or the IRBs.

This continuous feedback loop is designed to ensure the safe execution of a clinical trial, and requires close cooperation among the researchers, the sponsoring organization and the DSMB.

Read the official statement from NIAID regarding the AstraZeneca data: