Data and Safety Monitoring and Reporting

Data safety and monitoring boards (DSMB) are comprised of a group of clinical experts, statisticians, and other representatives with pertinent experience, who collectively monitor the data and conduct of ongoing clinical trials to ensure the safety of trial participants and the integrity of the trial. Over the years, the frequency of the use of a DSMB has increased; its mandate has been expanded to evaluate interim efficacy results, make recommendations for early termination of a trial, conduct sample size reassessments, and support the technical aspects of a trial through other recommendations. Given the complex issues a DSMB may face, it is important for a DSMB to gain the support the members need from relevant parties in order to function effectively and independently and to make informed judgments. This chapter starts by introducing when a DSMB is warranted, and provides guidance on the formation of a DSMB, highlighting approaches to ensuring adherence to data confidentiality and principles of independence. The chapter then provides an overview of different types of DSMB meetings, templates for a DSMB charter, and considerations for open and closed reports. Lastly, a listing of guidance documents on DSMB from regulatory agencies and others is provided for reference.