Shared Control: Novel Trial Design Works In COVID, But Will Sponsors Buy In?
COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.
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The World Health Organization is developing a new best practice guideline on improving the quality and efficiency of clinical trials and is keen to learn what role platform trials can play on this front and their acceptability by the clinical trial community.
The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.
New EU-wide guidance describes the factors that sponsors should consider when designing and conducting trials with complex innovative designs.