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DTSTART;TZID=Europe/Bratislava:20251211T130000
DTEND;TZID=Europe/Bratislava:20251211T140000
DTSTAMP:20260725T142018
CREATED:20251119T163614Z
LAST-MODIFIED:20251124T084245Z
UID:10000012-1765458000-1765461600@emwa.org
SUMMARY:Diversity and inclusion in clinical trials
DESCRIPTION:December 11th\, 13.00 CET \nDiversity and inclusion in clinical trials \nDarius-Jean Namdjou\, PhD \nUnderrepresentation of certain groups\, e.g. via gender\, ethnicity\, socioeconomic status and further parameters\, is affecting clinical trials\, particularly in late-stage development trials. The resulting inequalities in access to clinical trials have led\, as current research indicates\, to consequential issues concerning e.g. efficacy and/or safety of authority-approved medicines in these underrepresented populations. In agreement with the overall goal of a more patient-centric drug development\, the topic of inclusion to clinical development has been recently addressed by EMA in its Draft Reflection Paper on Patient Experience Data (PED)\, while US FDA’s thinking on diversity has been described in guidance documents on Diversity Action Plans for pivotal clinical trials. Holistically on a global scale\, both topics were addressed in the WHO guidance document on best practices for clinical trials. The scope of this presentation is to inform about current efforts to foster equality in access to clinical trials and to make the webinar participants aware of the corresponding developments affecting future global drug development. \nLearning objective: \nReceive the necessary knowledge on inclusion\, diversity and strengthening the patient voice in clinical development to start raising awareness\, including triggering thinking processes on respective practical implementation \nLevel: Intermediate \nTo register\, please click here
URL:https://emwa.org/event/diversity-and-inclusion-in-clinical-trials/
CATEGORIES:Webinar
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