Innovative clinical trials: Addressing the evolving needs of clinical research and participants with decentralised and complex trials

In general, innovation in clinical research often stems not only from aspiration – for example to increase accuracy and efficiency or to optimise costs – but also from shifts in social paradigms or from changes in circumstances that lead to changes in practices, as experienced during the COVID-19 pandemic. Indeed, the challenges clinical research faced during the pandemic led to changes in how clinical trials are conducted. Healthcare personnel had to come up with nontraditional ways to connect with their patients and patients’ families. Researchers had to develop new approaches since it was no longer possible to follow many everyday practices and because they had to answer even more complex questions – often with fewer resources. These challenges accelerated innovation in clinical research, particularly in the area of trial design. This article takes a deep dive into how design innovation has transformed clinical research by providing new operational approaches, such as those applied in decentralised clinical trials (PART 1), and new methodologies, such as those used in complex trials (PART 2).