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14 June 2023

Jason Cooper; Michaela Maria Freitag; Peter Jacko

In this session the speakers talk about platform trial designs covering different therapeutic areas.  Jason Cooper (AstraZeneca) discusses the feasibility of a platform phase II trial for moderate-to-severe asthma, motivated by the need to offset declining recruitment rates with more adaptive and efficient patient-cantered trials.  Michaela Maria Freitag (Charité – Universitätsmedizin Berlin) presents design considerations for a phase II platform trial in Major Depressive Disorder and discusses the selection of important design elements, such as allocation ratios and analysis methods as well as the operating characteristics of such trials under various realistic scenarios.  Peter Jacko (Berry Consultants) concludes the session with a presentation on designing and simulating a platform trial for rare diseases, discussing rules for adding new arms, randomisation procedures, statistical analysis, and operating characteristics of the various designs.

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