Are decentralized clinical trials (DCTs) here to stay? Probably — they proved their worth during the COVID pandemic. DCTs are trials in which some or all study activities occur away from traditional clinical trial sites. These trials can be more convenient for participants, thereby facilitating enrollment and diversity of subject populations.
The FDA has a newly issued draft guidance on DCTs. The draft guidance provides information on, among other things, centralizing study records and handling participant study visits. We encourage everyone involved in clinical research to read this draft guidance, as UAMS will likely consider participating in DCTs in the future. Note the guidance open for comment through August 1, 2023. Click on the link above to view the draft guidance and to access the comment link.