The Time for Decentralized Clinical Trials is Now
The FDA Draft Guidance on Decentralized Clinical Trials provides recommendations for clinical trial sponsors to incorporate virtual elements into clinical research.
Authors: Irena Lambridis and Dr. Jonathan Cotliar
Decentralized Clinical Trials (DCTs) continue to gain momentum based on the many benefits that they offer to patients, such as reduced travel burden, and easier access to groundbreaking clinical research. In turn, this greater access leads to more representative participant populations in drug development.
On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated draft guidance on decentralized clinical trials, providing recommendations for clinical trial sponsors as they incorporate virtual trial elements into their programs. The FDA recognizes that DCTs offer significant benefits, but they also require careful planning and coordination in the lead up to, and throughout trial execution. As the pioneer of decentralized clinical trials, Science 37’s approach to executing faster, more inclusive, patient-friendly clinical research complies with the FDA regulations outlined in this recent draft guidance.
In this new draft guidance, the FDA states that “remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible to trial participants.” As the FDA encourages this important approach, it also underscores the need for clinical trial sponsors to work with experienced vendors that can help navigate the complexities of DCTs while enabling patient safety from adverse events and the integrity of the trial data being collected within this novel approach.
The FDA's draft guidance highlights the importance of collecting accurate, complete, and reliable data, ensuring data privacy and security, and using mobile health technologies effectively. To facilitate virtual clinical trials, organizations conducting these decentralized trials not only are required to have full oversight of all study conduct that takes place in the home, but oversight that also extends into patient communities, including the utilization of local healthcare facilities, local healthcare professionals, and local clinical laboratory facilities. A deep understanding of the regulatory requirements and the architecture of items such as the Form 1572 and the delegation log, in addition to optimizing protocols for DCT conduct, are critical components of compliant and successful study execution.
The FDA further recommends that clinical trial sponsors use decentralized clinical trials to help increase diversity and inclusiveness in trial populations. By utilizing outreach through local healthcare institutions and bringing trial-related activities to participants' homes, the need for travel is reduced and potential participants who have difficulty accessing traditional clinical trial research sites can be better engaged, enrolled, and retained. Partnering with local healthcare professionals embedded within communities will improve trust and help overcome some of the cultural or linguistic barriers that exist in clinical research. This should ultimately improve diversity in clinical trial populations.
Decentralized clinical trials are now widely used in clinical studies across multiple therapeutic areas to expand patient access, improve patient experience, and deliver a more diverse participant population. The latest FDA draft guidance supports and promotes a decentralized approach to clinical trial design and execution. Conducting hybrid and decentralized clinical trials effectively requires experienced teams capable of managing the complexities of remote study conduct to prioritize patient safety and maintain high data quality.
- Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Guidance for Industry, Investigators, and Other Stakeholders, U.S. Food and Drug Administration