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Principles and Practice of Clinical Trials – a “Living Reference Work”…



Over the years, I’ve amassed a collection of textbooks that have proven useful at one stage or another. However, as time goes by, the only things they gain are a thin layer of dust and minor wear and tear. As clinical trial design and analysis practices change, I really wish they were gaining new and up-to-date content.


A few years ago I wrote a chapter on Bayesian Adaptive Designs for Phase I Trials with Michael Sweeting (University of Leicester) and Adrian Mander (Cardiff University) in Principles and Practice of Clinical Trials. Our chapter reviews novel approaches for clinical trials designed to find which dose levels of one or more treatments have a specific risk of causing severe adverse events in patients.


As well as introducing the methodology behind these trial designs, we also provide example studies where these designs were used in practice. One example aims to find the maximum tolerated dose combination of nilotinib and imatinib in adult patients with imatinib-resistant gastrointestinal stromal tumours. Another is the Matchpoint trial, which aims to find the dose of ponatinib that, when given with chemotherapy in patients with chronic myeloid leukaemia, maximised the chance of a treatment response whilst controlling the risk of toxicity.


We submitted our chapter to the Editors at the end of 2018 – quite some time ago! After a period of quiet, it was ready for publication along with the other 91 chapters. Whilst pleased our work was finally available, I was concerned that there might be a knowledge gap. Trial methods development is continuously evolving; with at least two years between submitting our chapter and having it published, I wondered whether the methods and examples we used would become out-of-date sooner than we liked to think.


I was heartened to find out that the publisher Springer has made this book a “Living Reference Work” – an online-first collection of chapters that is constantly being developed and refined. We can update our chapter with new knowledge and examples prior to the book’s final print publication (due in mid-2022). More excitingly, all chapters are free to download and have their own digital object identifier, making them fully citable for other researchers.


We have the opportunity to keep our work current, showcasing the latest methods for trialists in an accessible way and with examples of their use in practice. What impressed me more was that such Living Reference Works are easily citable and free to download. So, if you’re looking for new reading across all aspects of clinical trials – from ethics, regulation and oversight to design, conduct and analysis – go check out Principles and Practice of Clinical Trials and take your pick!


Graham Wheeler

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