Decentralized clinical trials (DCTs) focus on bringing an increasing proportion of a trial’s activities to the patient’s home, as opposed to bringing the patient to a trial site. The ultimate aim is to meet patient needs and improve the patient experience, and the key to achieving this is technology i.e., utilizing tools like e-consents, telehealth solutions, and wearables that facilitate remote monitoring. However, when it comes to DCTs, the pace of innovation outstrips the pace of regulation.
The industry is moving rapidly to embrace this new approach, but there are key areas of uncertainty as to how DCTs sit within the legal and regulatory framework. While we await more formal guidance from regulators, CROs and sponsors are already building on lessons from the pandemic to roll out elements of DCTs on a local, regional, and global basis.
In our article in the Life Sciences Magazine (here), Julia Gillert and I have set out key points on the legal landscape for DCTs.
We do not necessarily have robust and complete guidance from regulators on full DCTs, which means there are gaps, questions and grey areas emerging. Early engagement with the relevant ethics committee and regulator will be key.