Data and Safety Monitoring Boards

Wed, Oct 22, 2025, 1:00 pm - Wed, Oct 22, 2025, 2:00 pm

Presenter: Haley Hedlin, PhD

Clinical trials are essential to improving health and making strides in medicine; however, ethical and safety issues are common. Participants are potentially exposed to experimental treatments and at times may also belong to a vulnerable population. For this reason, independent oversight is crucial. Data and Safety Monitoring Boards (DSMBs, also called Data Monitoring Committees) are charged with playing this vital role of providing such oversight and upholding the integrity of the trial.

Haley Hedlin is a Senior Biostatistician and the Associate Director for the Clinical Trials Program within the Quantitative Sciences Unit in the Department of Medicine at Stanford University. The Quantitative Sciences Unit is a group of collaborative data scientists who work on a wide range of studies. In her position, she collaborates closely with clinical researchers to design and implement studies and apply statistical methods across the fields of medicine and public health. She has interacted with dozens of DSMBs in the role of an independent statistician presenting to the DSMB; as a DSMB member and chair; and as a clinical trialist whose trial is being overseen by a DSMB.

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This session will provide an overview of DSMBs and what can be expected from the statistician presenting to the DSMB and from those who serve on a DSMB. Haley Hedlin will present information on how the DSMB interacts with the study team, what a DSMB meeting is typically like, what materials are needed for a DSMB meeting, and statistical concepts that are commonly discussed. Examples from DSMB reports will be shared along with other materials like the DSMB charter. This session will end with time for Q & A to allow participants to ask additional questions they might have about DSMBs.