Data Monitoring Committees (DMCs) are empaneled to safeguard trial participants and uphold the scientific integrity of a trial. DMCs review unblinded clinical trial data and issue recommendations to sponsor liaisons empowered with decision-making authority. When assessing risk-benefit, are DMCs typically provided with benefit summaries by default or upon request?

Benefit data on how a participant feels, functions, or survives do not always equate to formal inferential efficacy summaries.

Join us for an insightful webinar where our experts will examine scenarios and explore how appropriate data summaries can best support DMCs to assess risk-benefit.

Key Topics

• How DMCs consider alternative therapies and trials available to participants when making a recommendation
• Which data summaries reflect participant benefit
• How sponsors can best support DMCs with access to appropriate summaries before requests for the summaries become informative
• Examples of planning for risk-benefit assessments

Speakers

• Becky Gatesman, Global Head of Axio
• Emily Woolley, Senior Director Biostatistics