CONTEXT: Opinion piece on the future of clinical research beyond COVID focusing on decentralised research and RWR | Embracing the concept of making clinical data more “real” (and meaningful?) by engaging patients in their “real’ environment
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1. “And as we look ahead to conducting research in the post-pandemic world, it will be critical for sponsors and CROs to continue incorporating decentralized tools and technologies not just as an emergency stop-gap measure to ensure trial continuity, but also as part of a broader, more patient-centered approach to study design and conduct that can be applied to studies in each stage of development.”
2. “Decentralized Clinical Trials (DCTs)—generally defined as studies that use telemedicine and/or digital health technologies to conduct some or all trial activities outside of traditional trial sites—were not borne during the pandemic at all.”
3. “A November/December 2020 study from the Tufts Center for the Study of Drug Development, for example, found that 55% of active clinical trials transitioned to remote and virtual models during the pandemic, partially decentralizing trials by adding DCT methods to existing trial protocols.”
4. “Although such resource-heavy, study-specific training was/is certainly appropriate for continuity during the pandemic, converting traditional study sites to virtual study sites reactively adds significant time and cost to the clinical trial cycle time and cannot be considered a feasible long-term strategy.”
5. “For studies with challenging-to-enroll populations—such as oncology, CNS disorders and rare diseases—an integrated DCT strategy leveraging each of these patient-centered components would allow sponsors and CROs to conduct trials faster, more efficiently, and more aligned with both patient-important outcomes and regulator expectations.”
Source URL: https://www.pharmexec.com/view/refining-rethinking-and-decentralizing-clinical-research