Understanding the Role of a Data and Safety Monitoring Board: How DSMBs Support Human Subjects Research

The Clinical Research Podcast Series at NYU Langone Health

Clinical trials often require the use of a data and safety monitoring board (DSMB) but understanding the role of DSMB in human subjects research can be confusing for some. Dr. Erinn Hade highlights NYU Langone Health’s Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB). In a recent discussion with Dr. Hade, HRP’s Robert Maril helped get some clarity on DSMBs. Dr. Hade shared her insights regarding the role of a DSMB in human subjects research including the services CTSI provides in support of DSMBs, the review process, submission requirements and reporting responsibilities of investigators.

Dr. Erinn Hade is an Associate Professor of Biostatistics in the Department of Population Health at NYU Grossman School of Medicine. She is also a researcher, a trial statistician, and a member of the NYU Langone Health CTSI DSMB.

Discussion Breakdown:

0:44 - When the NYU Langone Health CTSI Data and Safety Monitoring Board (DSMB) started?

1:00 - NYU Langone Health created its own DSMB

1:53 - The difference between and IRB and a DSMB

4:23 - DSMB Composition

6:14 - When researchers should connect with the DSMB regarding their human subjects’ research

8:59 - When use of the CTSI DSMB is required

10:27 - The DSMB review process and submission requirements for new studies

12:29 - Interim safety data reporting requirements

15:15 - How the DSMB member experience has impacted Erin’s own research

17:09 - Advice on developing data and safety monitoring plan (DSMP)

18:51 - Resources for DSMP development

20:30 - What the CTSI DSMB has in store for the future

Helpful Links:

• NYU Langone’s Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB) Webpage
• Data and Safety Monitoring Guidance (NYU Langone Health- IRB)
• Data and Safety Monitoring Plan Guidance (NIH)
• Data and Safety Monitoring Plan (Independent Monitor) Example