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Clinical Trials Insight Volume 2 2021


Editorial


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


Commercial Sales manager Nathan Park


nathan.park@progressivemediainternational.com Client services executive Derek Deschamps Managing director William Crocker


Clinical Trials Insight is published by Progressive Media International.


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Lasting changes A


nother issue, another variant. The trend of frequent mutations is becoming all too familiar as the world fails to close the vaccine gap by distributing vials to developing nations. For the world of clinical trials, the ongoing disruption caused by the pandemic is leading to new practices that many believe will endure into the future to some extent. One of these was born out of necessity; as restrictions put in place to curb the spread of Covid-19 has prevented in-person trials, organisers have been forced to adopt direct-to-patient protocols that involve participants having drugs sent to, and at times administered, in their own homes. On page 20, Andrea Valentino finds out from two experts in the field why elements of decentralisation will be present in more clinical trials. Trialling vaccines was a key part of the process that led to the Pfizer and AstraZeneca jabs being available for safe and effective use within months, rather than years. But this speed was unprecedented and, on page 13, Monica Karpinski examines the unique set of circumstances that enabled it, as well as explaining why the experience could lead to companies producing future vaccines faster than has typically been the case. One often overlooked part of clinical trial organisation is the sourcing and purchasing of ancillary supplies. The timely delivery of these items can easily be the difference between a study starting on time or being delayed, and that’s why our logistics story on page 26 focuses on how the worldwide shortage of certain medical items impacted ancillary supplies. Elly Earls learns from two major companies involved in sourcing them how they kept trials running throughout the pandemic.


Other topics in this issue include the challenges of trialling drugs made to target rare diseases, the benefits and drawbacks of adaptive trial designs and the importance of packaging to keeping participants in the dark about whether they’re in the control group or not. Sponsors and organisers continue to be resilient in the face of ongoing pressure, and what they’ve had to do to survive may well become key elements in the perpetual evolution of the disciplines involved in bringing new treatments to market.


UK £58 EU €92 US $119 RoW $120 UK £93 EU €144 US $190 RoW $191


Peter Littlejohns, editor


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