July 3, 2023
White Paper from Astrix Clinical Services
The US Food and Drug Administration (FDA) has released a draft guidance document on decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. This guidance outlines the FDA’s recommendations for designing, executing, and evaluating these trials and provides guidance on ensuring patient safety and the accuracy of the data generated. Additionally, it includes information on how sponsors of these types of trials can use emerging technologies and remote monitoring methods to conduct the trials while still ensuring the safety of patients and the accuracy of the results.