Decentralized Clinical Trials Global Trends: Positive Impacts and Advances

As summer of 2025 begins, it is reasonable to contemplate the extreme impact of substantial growth with general remote activities within in recent years across the world.

Throughout this insight, Blair Sirockman, Account Manager in Clinical Trials Optimization, reflects on the global shifts in operations, management, and logistics including altered ways of conducting events, appointments, and even lifestyles. While the influence of the COVID-19 pandemic being the most recent primary catalyst for change, there are ways in which healthcare and patients have been creating solutions with remote operations over the last decade that have accelerated clinical trials towards inspiring change and amplified global study performances.

Decentralized Clinical Trials (DTC)

For medical research studies, specifically with clinical trials operations, there has been an avenue for patients to participate from different perspectives depending on the study criteria, therapy area, and other considerations such as assessment of events and patient population. Decentralized clinical trials (DCT) include conveniently located appointments and remote activities to expand pathways for participants. Participants can access remote activities through telehealth appointments or in-home visits with clinical trial personnel. In giving participants the option to conduct activities at local facilities as opposed to research medical centers, this allows greater overall engagement and increases inclusivity by reducing barriers such as participant’s access to trial sites. Participants can also benefit from remote appointments with healthcare professionals by limiting travel burdens and allowing patients to feel comfortable at home during discussions.

Decentralized Clinical Trials & Regulatory Impact

From a global perspective, there are many different approaches to DCTs across regions and within regulatory boards. For example, the United States Food and Drug Administration (FDA) has publicly and strongly supported the advancement of decentralized clinical trials, especially due to accelerated advanced technologies, specifically digital health technologies (DHT). DHT related to drug development have been critical in DCT progression which include electronic sensors and computing platforms that allow data to be digitally retrieved from participants quicker and more efficiently. Portable DHTs can be worn, ingested, or included in participants homes, extracting real time data remotely. Healthcare professionals and trial personnel are encouraged to share findings impacting DCT through DHT performance. The US FDA has created guidance documents for use by clinical trial operations teams which aid with consistency across decentralized clinical trials activities to hold the same standards as traditional executive clinical trial activities. Guidance document includes focus on DCT design, conduct of in-home appointments, roles and responsibilities of sponsors and trial personnel, obtaining informed consent (IC), packing and shipping of investigational products, and safety monitoring of participants in DCT. While this guidance is US-focussed, the Decentralized Trials & Research Alliance (DTRA) have developed a Global Conduct Map that provides information for regulatory, privacy and legal representatives involved in DCT. It is evident, from a global perspective, there are strong levels of support for remote participation and new ways of finding efficiencies with trials.

Decentralized Clinical Trials & Upcoming Advancements

DCTs have been heavily influenced by Artificial Intelligence (AI) trends and advancements related to digital tools and analytics. For clinical trials operations, this can be seen in areas of patient consent, using various digital platforms to capture data. In my most recent article, linked here, it is clear post-COVID pandemic AI growth is unprecedented; albeit the trajectory and full potential holds a lot unknown. While global human activity as a whole has returned to on-site, in-person events and workflows, there have been trends and data extracted from the extreme surge in remote functions in the years following the COVID-19 pandemic, which are positively impacting processes. These insights are impacting medical research by allowing sponsors and patients to effectively advance by breaking down barriers such as patient geolocations relative to hospitals and increasing participation with diverse patient populations. With all AI machines and digital technologies, it is crucial our healthcare professionals and patients continue to strive towards utilizing such advancements with data protection and privacy at the forefront of human decision making.

Decentralized clinical trials processes and remote participation data are developing at rapid pace on a global stage to vastly shift study efficiencies, access diverse participation with potential to positively impact overall drug development and medical advances. While trends clearly display exponential growth and similar to all fields of advancing digital tools and technologies; the path forward is full of potential and change. The healthcare and medical research communities are dedicated to utilizing decentralized clinical trials as a pivotal and innovative way to enhance recruitment, enrollment, and ultimately product development and data outcomes.

If you have questions related to decentralized clinical trials and how this may impact study protocol design, enhance recruitment strategy, or increase overall study performance, please reach out directly ([email protected]) or email our Clinical Trials Optimization team at [email protected].