As of May 2023, the FDA released an updated draft [1] to the decentralization of trials for drugs, biologic products, and medical devices [2]. This is an attempt to make it easier on and support the capabilities of running a clinical trial; allowing participants to take place in the clinical trial from their homes and local healthcare facilities rather than a single centralized location. With the use of digital health and current technologies, participants can easily be monitored from afar. This includes telehealth communications and data-collecting technologies such as cell phones and smart watches.
Removing the distance barrier between possible participants and the centralized location of where these clinical trials are commonly conducted, allows for just about anyone to participate which can facilitate the inclusion of socio-economic minorities. It also makes the clinical trial more personable as you are not dealing with a centralized that is either inconvenienced by travel-time or an uncomfortable location. Also, not having to leave your house allows participants who are home-bound or incapable of driving long distances to participate without having to change their lifestyle for the clinical trial.
Overall, the inclusion of more diverse participants in a clinical trial is important for accuracy and minimization of confounding variables such as socio-economic status. Allowing participants with rare diseases or mobility issues into the trials gives a whole new population of possible participants that were previously excluded. Ultimately, decentralizing clinical trials seek to increase treatment options and improve patient outcomes for future generations [2].
If you need help understanding the regulations and rules for decentralized clinical trials for FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] FDA. (2023, May). Decentralized Clinical Trials for Drugs, Biological Products, and Devices. U.S. Food and Drug Administration. https://www.fda.gov/media/167696/download
[2] FDA. (2023, May 02). FDA Takes Additional Steps to Advance Decentralized Clinical Trials. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-steps-advance-decentralized-clinical-trials
