The future of clinical trials is decentralized and not one size fits all

An Expert View from Fiona Maini, principal, global compliance and strategy at Medidata Solutions, a Dassault Systèmes company.

Remote technology solutions in clinical trials, such as electronic patient diaries, and wearables and sensors, have been around for some time, but it’s taken a few years for wider adoption. These tools enable patients to participate in clinical trials from the comfort of their own home or preferred location, and they reduce the burden associated with partaking in ‘traditional’ trials. In trials using such technologies, also called decentralized clinical trials (DCTs), site visits are limited, which provides patients with some flexibility and tools to alleviate the burden associated with manual reporting, such as of drug intake.

In a post-COVID-19 world, it has become obvious that trials often function better when they use these solutions. Prior to the pandemic, these solutions were not as widely available as they are now, and regulatory guidance on their use was not as extensive. The industry’s approach to clinical trials changed as a result of the pandemic, but how exactly has the pandemic played a role in the wider adoption of remote technology in clinical trials, and how supportive have regulators been?