The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” offers guidance on DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs.
The guidance calls for a physical location for DCTs where all clinical trial-related records for participants under the investigator’s care are accessible and where trial personnel can be interviewed.
When conducting non-inferiority trials, the FDA notes that variability and precision of data obtained in a DCT may differ from data in a traditional site-based clinical trial and recommends consultation with an FDA review division when planning a non-inferiority trial in a DCT setting.
Regarding the role of local healthcare providers (HCPs) in the DCT, local HCPs contracted to provide trial-related services that are part of routine clinical practice and where a detailed knowledge of the protocol or the IP is not required are generally not considered investigators and should not be included in the IDE list of investigators. However, these local HCPs should be included in a task log.
Quality control measures should also be in place to reduce variability of documentation of vital signs, physical examinations, and evaluation of adverse events among different HCPs. “The type and scope of quality control measures should be tailored to the criticality of the data and the complexity of procedures done by the local HCPs,” per the guidance.
Informed consent can be performed remotely, but all subjects must be given a contact for answers to pertinent questions about the research and research subjects’ rights as well as whom to contact in the event of a research-related injury. It should also describe who will have access to the trial participant’s personal health information obtained during the DCT.
Stakeholders can submit comments on the draft guidance before 08/01/23.
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