Safeguarding Clinical Trials – Part 2: Best Practices for Statistical Reporting & Interim Analyses

Data Monitoring Committees (DMC) or Data Safety Monitoring Boards (DSMB) serve as guardians, meticulously reviewing trial data and making recommendations to sponsors to continue, stop, or modify a trial based on accumulated study data. In February 2024, recognizing the evolving landscape of clinical research, the Food and Drug Administration (FDA) released a draft guidance on the use of DMCs in clinical trials. The guidance aims to modernize and clarify expectations for DMC involvement, and ultimately to safeguard participant well-being and trial integrity. 

As a follow-up to our first webinar on safeguarding clinical trials, our expert panel will explore how Independent Statistical Reporting Groups (ISRG) can effectively organize and present data to DMCs in alignment with the latest FDA draft guidance.

WCG’s speakers will delve into:

• How ISRGs structure data to support meaningful DMC review.
• What data should be prioritized and presented under new regulatory expectations.
• The DMC’s responsibilities during interim analyses (IA).
• Best practices for ISRGs supporting IAs.
• Steps ISRGs must take to ensure DMCs have timely access to appropriate data.
• Strategies for managing timelines to ensure ISRGs have ample opportunity for data transfers and reporting.

Whether you’re a clinical trial sponsor or regulatory affairs professional, this session will provide practical strategies to enhance data oversight and decision-making in your studies. Register today to reserve your spot.

Did you miss part one in this webinar series? Watch the recording on-demand here.