Decentralized Clinical Trials Adoption and Challenges

This article segment is part of a two-part series discussing decentralized clinical trials (DCTs). It outlines the evolution of DCTs, particularly accelerated by the COVID-19 pandemic, and highlights the growing acceptance among sponsors and pharmaceutical companies. The text emphasizes the importance of staff readiness at study sites to adapt to rapid changes and the role of regulatory guidance in addressing hesitancy towards DCTs. It details how DCTs can potentially resolve longstanding issues in traditional trials, such as time, cost, and participation rates, while also addressing the urgent need for diversity among trial participants. The article discusses the challenges faced by clinical trial sites, including the burden of new technologies and the necessity for change management. It also mentions the involvement of regulators in developing guidance for DCTs to enhance patient safety and data integrity. The article concludes with insights on the future landscape of DCTs and their expected impact on clinical research.