FDORA Section 3601 will require Sponsors to submit Diversity Action Plans when they submit key trial documents to the US Food & Drug Administration (FDA), and to monitor related enrollment targets on an ongoing basis. These rules will go into effect 180 days after the FDA publishes their final guidance on the topic. Given the complexity and need for advance planning associated with large pivotal clinical trials, as well longer-term considerations for evaluation of data across studies, Sponsors should begin considering how these guidelines might affect their clinical development plans now.
One area for proactive planning is the creation and implementation of monitoring plans to track enrollment goals and action plans to allow responsiveness to these data. It will be particularly important for Sponsors to develop best practices to track factors related to the FDA’s expanded definition of diversity. Data visualization software will play a key role in effective and timely monitoring of these enrollment objectives. In this talk, we will cover aspects of the Datacise® data visualization platform, which are uniquely suited to the monitoring of Diversity Action Plans.
This MMS Experts Insights Webinar is a must-attend event for Sponsors considering how to best prepare for and implement the FDA Diversity Action Plan guidance, a new ruling anticipated to take effect Q4 2025, to increase the strength and generalizability of future Marketing Applications.
Watch this Webinar to:
- Participate in a forward-looking discussion on how to best prepare for the new laws and FDA guidance around Diversity Action Plans
- Enhance clinical trial planning and discover best practices for tracking and responding to diversity-related enrollment goals using advanced data visualization tools like Datacise®
- Strengthen marketing applications by understanding how these new guidelines can improve the generalizability and robustness of your future marketing applications
What You Will Learn:
- The legal underpinning, evolution, and next steps for Diversity Action Plans
- Techniques for developing monitoring plans to track diversity-related enrollment goals using data visualization tools like Datacise®
- Insights into best practices for ensuring diverse participant representation in clinical trials, enhancing the strength and generalizability of study results
Who Will Benefit from Attending?
- Clinical development directors and professionals, clinical trial managers, and clinical operations leads
- Regulatory affairs and submissions professionals
- Research scientists, project managers, data managers, biostatisticians, and compliance officers