Noor, Nurulamin; (2023) Improving trial conduct for late-phase, randomised clinical trials that utilise innovative trial designs and platforms. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

During my PhD I assessed how novel approaches could be used to improve trial conduct, specifically across late-phase trials utilising innovative designs, and related findings back to my sub-speciality and area of clinical interest, a condition called Inflammatory Bowel Disease (IBD). My thesis focused on complementary topics across five main chapters. First, I reported on the experiences and challenges for investigators in delivering a biomarker-guided trial in Crohn’s disease (CD), seeking to stratify management based on different risk profiles of CD. Second, I expanded on this concept of heterogenous outcomes, by addressing a novel treatment strategy for patients with lower-risk CD. Third, given the impact of Coronavirus disease (COVID) on my studies, I was able to modify my doctoral study plans and assess the impact of COVID on delivery of IBD clinical trials. This allowed me to better understand challenges to overcome and the need for more efficient trial designs in IBD. Fourth, I evaluated the conduct of multi-arm, multi-stage (MAMS) adaptive platform trials across disease areas, in order to understand how best to implement a MAMS platform approach to higher-risk CD. Fifth, I examined issues of conduct for Data Monitoring Committees (DMCs), with specific focus on both novel designs and the potential role for patient and public involvement/engagement. I report novel findings in each chapter. These a) help increase understanding on how to deliver innovative trials in the IBD field; b) provide a global consensus on the concept of biological treatment cycling for lower-risk patients with CD; c) demonstrate the lasting impact of COVID on IBD clinical trials; d) support increased understanding on the conduct of MAMS protocols and map out potential application to patients with higher-risk CD; e) highlight factors for consideration by DMCs overseeing trials using more innovative designs.

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