Alison Occhiuti Kroell, Associate Director Clinical Operations, Magenta Therapeutics, and Nicola Goatman, Director Commercial Insights, MRN
“Decentralized” trials (also known as hybrid, remote, or virtual trials) is an umbrella term – covering a broad range of services and solutions that can be mixed and matched depending on the circumstances, preferences and requirements of the patients, clinical sites and sponsors. Given the research and evidence available about decentralized trials, this highly customized trial model should be attractive to sponsors. With ~10% of clinical trials started between 2014 and 2022 incorporating DCT elements, why is the adoption of something that appears so beneficial not more widely adopted?
Implementing innovation goes through the well-known journey of the peak of early adopters, then to the adoption of pragmatists and conservatives and finally to sceptics – a slow climb to widespread adoption and value. With clinical trials, most early adopters will add some decentralized solutions to the traditional study design to support their patients, but widespread adoption across portfolios to drive recruitment and retention as part of a patient-centric model appears to be far off. Even though clinical trial patients and patient advocacy groups have expressed their desire for decentralized options, these solutions can be seen as back-up options or “nice to haves” in case other tried and tested approaches fail to deliver or in other exceptional circumstances, such as a worldwide pandemic stopping the clinical trial industry in its tracks, it is the exception, not the norm. So, what is preventing widespread adoption?