Current Developments and Regulatory Trends in Clinical Trial Design

Description: This session will look at selected examples of current global trends in clinical trial design and thus Regulatory Affairs development work. These trends are deemed relevant for developers/sponsors - especially their Regulatory Affairs staff -, clinical trial participants and regulators. This session will reflect on an important concept for early clinical development, as well as on an increasingly relevant aspect for late-stage development trials.
More particularly, this session will explain, based on case studies, the concept of enrichment, adaptive, seamless, basket and umbrella trials and discuss their benefits and risks for developers/sponsors. We would also like to invite views of regulators from EU regulatory authorities on these trials, and what criteria would be applied in determining acceptable trial designs that would be safe but also efficient to help address unmet medical needs. The topic and case examples should engage developers, regulators and sponsors.
Furthermore, underrepresentation of certain groups, e.g. via gender, ethnicity, socioeconomic status and further parameters, is affecting clinical 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 communications on patient experience data, 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 recent WHO guidance document on best practices for clinical trials. The scope of this part of the session is to inform about current efforts to foster equality in access to clinical trials and to make fellow Regulatory Affairs staff aware of the corresponding developments affecting future global drug development.