Regulatory Recommendations For Decentralized Clinical Trials: Considerations For Implementation

Decentralized clinical trials (DCTs) are on the rise, and while they increase accessibility for participants, they come with unique challenges. In a recent article for Healthcare Business Today, 4G Clinical’s Senior Director of Strategy, Neta Bendelac, discusses the European Medicine Agency’s (EMA) recent recommendations on the management of decentralized clinical trials and the impact this regulation has on clinical trial operations.

Here's a short excerpt.

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The last three years have catapulted the prevalence and demand of Decentralized clinical trials (DCTs), leaving contract research organizations (CROs) and sponsors scrambling to understand how to best implement and facilitate DCTs into their daily operations. With a 14.8% CAGR and a market value expected to reach almost 19 million by 2028, regulators such as the United Congress and the European Medicines Agency (EMA) have recently stepped in with recommendations on how to best manage decentralized elements of clinical trials, including the use of digital tools in decentralized procedures.

While decentralization might increase the accessibility of clinical trials to participants, it comes with new challenges that have to be carefully managed by CROs, vendors and patients.

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View the complete article at Healthcare Business Today.