Credit: Svyatoslav Lypynskyy/Adobe Stock Risks and Liabilities Relating to the Emergence of Decentralized Clinical Trials
The COVID-19 pandemic created an environment to drive the exponential growth of alternatives to traditional, site-based clinical trials such as remote/decentralized trials.
May 11, 2021 at 11:30 AM
6 minute read
Clinical trials are essential to assess both the efficacy and safety of new pharmaceuticals, medical devices and other health care-related products. In recent years, the use of remote/decentralized clinical trials has slowly grown alongside the technology that enables their application. The COVID-19 pandemic created an environment to drive the exponential growth of these alternatives to traditional, site-based clinical trials so that trials in progress could continue and trials with imminent start dates could commence.
It is expected that the use of decentralized clinical trials will continue due to their numerous benefits as compared to site-based clinical trials. 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. However, along with these benefits come many liability concerns, particularly in the areas of data verification, privacy and informed consent.
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