Key Takeaways From The FDA Guidance On DCTs

By Atul Gupta and Akash Gadgade

In recent years, there has been a significant increase in the adoption of decentralized trials (DCTs), largely catalyzed by the COVID-19 pandemic. The U.S. FDA defines DCTs as trials in which trial-related activities occur at locations beyond traditional sites. According to a study published in Forbes, the degree of decentralization in clinical trials prior to the pandemic was approximately 43%. However, by the year 2022, this figure had risen to 55%.