FDA Expected to Issue Draft Guidance on Decentralized Trials in 2021
Details of the FDA’s draft guidance on the operation of decentralized clinical trials due out this year are starting to emerge, with an expected emphasis on endpoint analysis, data quality and control, and the appropriate use of electronic informed consent (eConsent).
Sarah Blankstein, an associate in the life science group at Ropes & Gray, said the agency is also expected to incorporate into that guidance some of the principles it laid out in two 2020 guidances on the conduct of clinical trials during COVID-19, including recommendations for remotely collecting data and special statistical considerations presented by such data (CenterWatch Weekly, June 22, 2020).
At an FDAnews webinar last week on the FDA’s guidance agenda for this year, Blankstein said that data quality and control is “anticipated to be a significant point of discussion in the guidance.”
Other topics that may be addressed include recruitment, greater accessibility to clinical trials and control of investigational product shipped directly to trial participants, she said.