Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. Decentralized approaches reduce the burden of a clinical trial on the patient, accelerate enrollment, improve retention, broaden the diversity of the patient population and potentially shorten the study timelines. As with any new process in a regulated industry, the challenge lies in the continually evolving landscape.
The decentralized paradigm is shifting, and as the landscape evolves,
we should expect that the regulatory guidelines will evolve as well. In this white paper, we detail what considerations are helpful when laying the course for a successful clinical trial, as well as managing and effectively communicating learnings from your decentralized studies to inform regulatory guidelines going forward.
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