The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently acknowledged the growing role of decentralized elements in the conduct of clinical trials and offered recommendations for their use, with a focus on ensuring trial participant safety and data integrity.
Clinical trials of medicine products already have adopted several decentralized elements, including electronic diaries, wearables, phone calls, and online appointments. However, the appropriate use of these elements is dependent on the type of clinical trial, the trial population, the disease being treated, the trial participant’s condition, the type of medical product, as well as the product’s characteristics and stage of development, the agencies wrote in a recommendation paper issued on 13 December 2022…
