Issues in data-monitoring for complex clinical trials

OSP: Can you tell us a bit more about the Sally Hollis Memorial Lecture?

JV-R: ​The Sally Hollis Memorial Lecture was established in 2021 in memory of Professor Sally Hollis. Sally was a much-loved and highly respected member of not just the Phastar team but the wider medical statistics community. Sally was best known for innovation. She was always thinking about how to improve things and she really placed herself at the forefront of that interface between academia and industry. That is why the lecturer alternates each year between academia and industry – to represent the substantial cross-discipline impact Sally had.

DA: ​I knew Sally so I felt really honoured to be asked but I also wanted to carefully consider what I should talk about. I thought of trial complexity and data monitoring because we do not know how to overcome all these issues, which makes it academic, but it is very much relevant to industry because of the impact on clinical trials.

Pic: Deborah Ashby, interim Dean of the Faculty of Medicine, Imperial College

OSP: How have clinical trials changed in recent years and what has driven this complexity?

DA:​ While two-group trials are the bedrock of the pharmaceutical industry, increasingly people are questioning whether they are the most efficient method. New trial designs are busting the relatively straightforward framework we have all learned.

JV-R: ​The pandemic certainly sped up adoption of these more complex innovations, for example, decentralised clinical trial (DCT) models and platform trials. It just accelerated the industry in so many ways. We also saw a much more collaborative approach – everybody just came together to make it work.

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