Among the meetings of a Data Monitoring Committee (DMC), the organizational – or kick-off – meeting is one of the most important to guide the DMC’s future oversight of study participant safety and trial integrity. However, in the rush to form the DMC and to meet before recruitment begins, minimal planning often goes into this meeting. Because this will be the only meeting where the DMC is still naïve to interim study data, the organizational meeting provides opportunity to anticipate issues that may occur during the DMC’s monitoring and to discuss potential courses of action in an open forum with those from the Sponsor and the independent Statistical Data Analysis Center (SDAC) that supports the DMC.
During this webinar, we will hear from Matt Downs, MPH, from WCG Statistics Collaborative, on his perspectives on organizational meetings as an Independent Reporting Statistician to the DMC.
Some topics we will discuss are:
- The Independent Statistician’s role
- Example content and structure of the organizational meeting
- Elements of the DMC charter
- Critical discussion points to address during the meeting
- Clarification of communication paths during the DMC’s safety monitoring
- Matt Downs, MPH, Statistical Scientist, WCG Statistics Collaborative
- Dave Meadows, President, Scientific & Regulatory Review Division, WCG