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New Challenges for a Data Monitoring Committee
Session Chair(s)
Yeh-Fong Chen, PhD
Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
Food and Drug Administration, United States
Data monitoring committees (DMCs) can monitor the safety of a drug and weigh risk and benefit for stopping a trial early. In this session, we will discuss the importance of DMCs concerning the best practices of maintaining confidentiality of interim data and the recent Part 15 public hearing. The main focus will be how careful consideration of statistical inputs (e.g., planning for multiple looks) will improve DMCs’ efficiency and ensure the trial’s integrity.
Learning Objective : Describe the procedures and issues associated with organizing a data monitoring committee (DMC); Discuss the proper use of the DMC; Explain best practices of maintaining confidentiality of interim data to ensure trial integrity.
Speaker(s)
The Role of DMCs in Drug Development and the Importance of Confidentiality of Interim Results
Lisa LaVange, PhD
University of North Carolina at Chapel Hill, United States
Professor Emerita
DMC Review of Accumulating Safety Data: Confidentialty Issues
Martin Rose, JD, MD
FDA, United States
Medical Officer (Team Leader), OND, CDER
DMCs: Importance of Maintaining Confidentiality to Minimize Bias
Walter Offen, PhD
AbbVie Inc, United States
Global Head of Statistical Innovation & Safety Statistics