Navigating FDA's Diversity Action Plan Draft Guidance: From Strategic Planning Through Study Success, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn about the critical importance of a coherent and comprehensive diversity action plan-integrated approach. Gain valuable insights from industry and academic leaders on mitigating implementation challenges, from diversity action plan design, trial setup and conduct to data variability impact on clinical data interpretation.

TORONTO, Nov. 11, 2024 /PRNewswire-PRWeb/ -- In recent years, medical product development has increasingly adopted approaches that reflect real-world scenarios. The US Food and Drug Administration (FDA)'s updated Draft Guidance on "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies" marks a significant step towards achieving greater generalizability of evidence for intended patient populations.

For successful implementation, an integrated and clear strategy is essential. Engaging partners who can effectively recruit, motivate and retain patients from underrepresented populations, while analyzing data within a new paradigm that embraces greater heterogeneity, is crucial.

In this webinar, expert speakers will delve into how clinical trial sponsors and contract research organizations (CROs) can comply with FDA's guidance on developing and implementing diversity action plans. Specifically, this webinar will explore the concept of an "Integrative Approach" that aligns with diversity action plans and promotes equity in healthcare delivery and access.

The panelists will navigate the FDA diversity action plan guidance and seek to establish considerations for an integrative approach framework to enhance patient-centric drug development — from trial design to patient outreach, recruitment, retention, and variable data analysis and interpretation.

Register today to learn how clinical trial sponsors and CROs can align with the FDA's updated guidance on diversity action plans in clinical studies.

Join Sarah Thompson Schick (Moderator), Counsel, Life Sciences Health Industry Group (LSHI), Reed Smith LLP; Tinaya Gray, Global Head Diversity in Clinical Trials, ICON plc; Siân Ratcliffe Smethurst, PhD, SVP, Head of Quantitative Sciences & Development Operations (QSDO), Biogen; Dominique Demolle, PhD, CEO, Cognivia; and Ruby Madison Ford, Research Analyst, Tufts Center for the Study of Drug Development, for the live webinar on Wednesday, December 4, 2024, at 10am EST (4pm CET/EU-Central).

For more information, or to register for this event, visit Navigating FDA's Diversity Action Plan Draft Guidance: From Strategic Planning Through Study Success.

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