Exploring FDA guidance for modern Data Monitoring Committees

Implementing Data Monitoring Committees (DMCs) is increasingly significant for global clinical trial oversight. 

Regulators are sharpening their focus on how DMCs function and contribute to trial integrity amid increased globalisation, adoption of technology and increased use of adaptive study designs to ensure DMC management keeps pace with the modern clinical environment. 

The U.S. Food and Drug Administration (FDA) published draft guidance on DMCs in 2024, marking the first update to the original in nearly two decades. 

In this whitepaper, we explore the updates to the regulatory draft guidance, including:

• The expanding role of a DMC as a safety entity
• Special considerations for adaptive trial designs
• Best practices for assembling and managing DMCs
• Expanded statistical analysis, data and reporting guidance

Download the whitepaper to learn how these planned changes will affect the operational aspects of DMCs, including management, statistical analysis and delivery.