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Clinical Trials Insight Volume 2 2023


Editorial


Editor Peter Littlejohns peter.littlejohns@progressivemediainternational.com Sub-editor Pete Barden Group art director Henrik Williams Designer Martin Faulkner Production manager Dave Stanford Head of content Jake Sharp


Commercial Client services executive Derek Deschamps Sales manager Nathan Park


nathan.park@progressivemediainternational.com Managing director William Crocker


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linical trials can vary significantly in their levels of complexity, with the length, therapeutic area and number of patients taking part all contributing factors. But sometimes the wider trends of the pharmaceutical industry can be just as much of an impact, and that’s what we’ve seen as medicine is becoming more personalised, moving from small molecule drugs to more advanced therapeutics. In our cover story on page 31, Oladimeji Ewumi explores how this, and other factors, are changing the way that sponsors work with contract research organisations (CROs). He hears from two industry veterans on the topic. The pharmaceutical industry is evolving in more ways than one. The new Clinical Trials Regulation came into effect in January this year after a one-year grace period with the aim of harmonising regulatory compliance across Europe. This new set of rules came accompanied by a portal for applications and trial oversight, and on page 8, Jim Banks considers with expert input whether the regulator achieved its ambitions or if there’s more work to be done. With some therapeutic areas it doesn’t matter how good the technology at hand is, collecting and preparing data can be an uphill battle. This is especially true for oncology studies, and on page 14, Monica Karpinski explores the reasons why cancer, in particular, presents so many challenges as far as data management goes. Our focus on cancer doesn’t end here. For a long while now the promise of immunotherapy, in particular CAR T-cell therapy, has come with the caveat of needing enough apheresis collection and manufacturing capacity. On page 18, Andrea Valentino broaches the topic, with industry and medical experts weighing in on the barriers and potential solutions. Other topics covered in this issue include the evolution in labelling standards for products of human origin used in trials and an insight into how sponsors plan and respond to unexpected risks, using recent global events as examples.


Peter Littlejohns, editor


Clinical Trials Insight / www.worldpharmaceuticals.net


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