Decentralized trial tools and technologies are here to stay: A regulatory perspective

Decentralized clinical trial (DCT) strategies and tools such as telehealth visits, centralized monitoring, and remote source data verification (SDV) gained traction overnight during the Coronavirus Disease (COVID-19) pandemic, while already common practices such as direct-to-patient (DTP) drug delivery and home nursing became even more widespread.

Regulators rapidly adjusted the rules on protocol deviations in unprecedented ways to ensure the continuation of clinical research. For example, when the World Health Organization (WHO) declared COVID-19 a global pandemic in March 2020, both the FDA and EMA issued guidance on conducting clinical trials (CTs) that allowed the substitution of remote approaches for on-site activities. In all, dozens of health authorities (HAs) around the world published pandemic rules.

As some countries slowly start to bring the pandemic under control, many companies are wondering whether clinical research will revert to the old ways? The short answer is no.

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