The US Food and Drug Administration (FDA) is continuing support for decentralised clinical trials (DCTs) in a new draft guidance released May 2. As more sponsors embark on the DCT route, regulators are placing data interpretability, site management, and safety at the top of the bill.
Notably, the draft guidance encourages DCT adoption while noting that decentralised elements can impact the interpretability of results. While DCT use will not affect findings of superiority, it can affect the interpretability of trials assessing non-inferiority. This is because regulators say the variability and precision of data in DCTs could differ from that of traditional clinical studies.
Meanwhile, the FDA is encouraging sponsors to use remote monitoring and virtual sites provided in-person evaluation is not necessary. Even if a trial is entirely remote, however, there should be a physical location for storing trial-related records and interviewing trial personnel.
In addition, the guidance states sponsors can use qualified healthcare providers, such as nurses and doctors, to perform in-person assessments if the evaluation does not require extensive knowledge of the study protocol. This could reduce transportation burdens for patients, particularly if the healthcare providers perform home visits.
Above all, the draft guidance emphasises the need for in-depth explanations within trial protocols for all planned DCT elements. This includes detailing the planned flow of data, listing the third-party vendors responsible for data management, and specifying how adverse events identified remotely will be evaluated and managed.
Decentralised clinical trials
As DCT adoption continues to surge, experts say 2023 could be a pivotal year in defining how the field moves forward. Namely, sponsors and regulators are exploring methods for validating DCT elements and angling toward personalized clinical trials.
Still, decentralisation is not without risks. Sponsors must ensure that DCTs reduce patient burden, rather than increase it through added barriers, and that DCTs do not leave behind trial sites with less access and technological capability.
Decentralised Clinical Trial coverage in Clinical Trials Arena is supported by Huma.
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