13 May Partner Nicole Callahan’s article published in the New York Law Journal
In an article published in The New York Law Journal on May 11, 2021, Partner Nicole Callahan discusses the emergence of decentralized clinical trials accelerated by the COVID-19 pandemic, and the risks and liabilities associated.
“It is expected that the use of decentralized clinical trials will continue due to their numerous benefits as compared to site-based clinical trials,” Callahan writes. “These benefits include increased patient access and enrollment, increased diversity of a subject pool, easier and more frequent data collection, decreased participant burden in relation to time and travel, evaluation of possible confounding factors (sleep, physical activity) and decreased cost.”
While there are many benefits associated with virtual methods of clinical trials, liability concerns exist in the areas of data verification, privacy and informed consent.
“Decentralized clinical trials have the potential to significantly advance the evaluation of new health care vectors, including drugs and medical devices,” Callahan concludes. “Among other advantages, they are often less costly, have increased patient participation and retention, and provide a desired varied subject pool. With proper overall trial design, including considering safety issues, enhanced informed consent, telehealth, data privacy and security, and investigator oversight, decentralized clinical trials could significantly streamline the development of novel health care paradigms.”
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