Having produced an extensive DCT toolkit over the last four years for the planning and conduct of decentralized trials, ACRO was pleased to submit a comment to the FDA on Tuesday, August 1 in response to the Agency’s public consultation on its draft guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
Read the ACRO comment letter, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices”:
An enduring topic in DCT conversations is the nature of investigator oversight and responsibilities within a complex matrix of on-site and remote study staff (including those not in the employ of the investigator), along with parties who are not study staff. The ACRO comment examines the draft guidance’s introduction of a new requirement for investigators to create and maintain a “task log” of local health care providers (HCPs) who perform trial-related activities.
We note that the task log is not only a new requirement for DCTs, but also creates a different requirement for DCTs compared to conventional trials – holding DCTs to a separate standard. Moreover, we point out that the burden to investigators provides no gains in patient safety since local HCPs operate only within the scope of their license and in activities that do not require a detailed knowledge of the protocol, the investigational product, or the investigator’s brochure.
In our comment letter, ACRO asked the FDA to consider removing the task log requirement when the agency finalizes its guidance on DCTs. We look forward to continued dialogue on DCTs with the FDA and other regulators.