DSMB Best Practices and Behind the Scenes Insights

DSMBs are one of the most accepted ways to provide independent oversight of clinical trial safety data. How do you ensure your study’s DSMB meets regulatory agency expectations?

Learn DSMB administration best practices, including the importance of member selection and how to eliminate perceptions of bias. Gain expert insights on overcoming common challenges and lessons from the field gained from 20+ years’ DSMB leadership experience.

Learning Objectives:

• Summarize DSMB regulatory guidance from FDA and EMA
• Identify common best practices in administering a DSMB
• Develop mechanisms to ensure the DSMB is independent from study priorities and conduct
• Describe ways to select unbiased DSMB members
• Explain the role of the DSMB and how their oversight is different than IRB

• Presenters

Sara Raboin

PhD

Director of Operations
Yale Cancer Center

Barbara Schneider

PhD, MBA

Executive Director, Biostatistical Services, Advarra