Regulatory Hurdles For Decentralized Trials: A European Perspective

By James Streeter, Global Vice President, Life Sciences Product Strategy, Oracle

As COVID-19 began spreading across the globe, life sciences companies had to determine how to keep clinical trials running while making sure participants were safe. This, together with technology advances, accelerated the adoption of decentralized, or virtual, clinical trial methods such as telemedicine visits and remote data collection.

Decentralized approaches can help improve the patient experience, facilitate the collection of additional data, lessen the burden on clinical sites, and shorten the time it takes to get new drugs on the market. Although virtual methods have been around for some time, they were typically used in isolation. As more life sciences organizations experience the benefits firsthand, there has been a shift to greater adoption of decentralized trial components, either as a hybrid approach alongside traditional components or as a fully virtualized clinical trial. Regulators are also encouraging clinical trial designs that consider the needs of the most important people involved in a trial – patients and clinical site staff.

To gain insight into this trend, Informa Pharma Intelligence and Oracle Health Sciences conducted a survey of biopharmaceutical companies, CROs, and medical device companies involved in clinical trials around the world. The survey was conducted between September and November 2020 and included 252 qualified respondents, mostly from North America and Europe.