The hype around decentralized clinical trials (DCTs) continues to rise in the healthcare industry but sponsors have been reminded that the approach is not a “one size fits all” solution.
Speaking at a session on DCT strategy at the Outsourcing in Clinical Trials Southeast 2024 conference in North Carolina, Scott Palmese, Executive Director of Decentralized Clinical Trials at Worldwide Clinical Trials emphasized that not every study needs a DCT model.
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“Think of DCT as a category of tools in your toolbox alongside other site and patient-focused tactics,” said Palmese. “Then discuss these solutions with sites and use those site relationships to understand what systems sites use and how your proposed technologies or strategies could integrate.”
Palmese urged sponsors and CROs to engage with patient communities before adopting a DCT strategy. “Understand when patients will welcome decentralized tactics, and when they will not,” he explained. “If you don’t know the community, perhaps you should not be blanketing tactics that may not make sense and could drive patients away.”
A range of data collected from partner sites regarding attitudes towards decentralized trials was shared during the session, with some key trends emerging including how many trial sites are not adopting eConsent but believe it could be helpful for ease of documentation.
Home health was also called out by some sites as an area that sponsors and CROs do not implement well. Specific limitations noted included communication barriers with nurses and site bandwidth to correctly handle data transferred from nurses.
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By GlobalDataHowever, multiple clinical trial sites noted that giving patients options versus the traditional on-site approach is key to reaching underserved populations, especially in certain geographic areas.
In addition, some sites remarked that DCTs are better for non-interventional studies and not for oncology studies with one site noting that DCTs are typically a good idea for infectious disease, rare disease or metabolic disease trials.
