Decentralized Clinical Trials: Reducing Site Burden and Improving the Patient Experience

3-minute read

Given recent rates of change and innovation, the role of technology in clinical trials is always a key topic for discussion at NEXT London as new and exciting tools emerge. Over the past 25 years, Medidata has been creating innovative digital technology solutions for clinical trials and has gained considerable insight into some of the key trends in the sector, including the significant increase in the use of decentralization in trial conduct. The importance of reducing patient burden to encourage patient recruitment and improve the patient experience is well-established within the clinical research sector, and this remained a focus during many of this year’s sessions. One key development has been the rise of technologies available to researchers—both in adoption and variety—to decentralize elements of clinical trials, which successfully facilitates patient participation in trials largely from the comfort of their own home.

In a session focusing on the use of eCOA (electronic Clinical Outcome Assessment) technology in trials and how these can accelerate studies, Medidata’s Senior Director of eCOA Product & Science, Paul O’Donohoe, spoke about how these solutions, allowing patients to fill out clinical outcome assessments remotely, could be seen as the “foundation of […] DCTs more broadly”. But despite a reputation for being at the forefront of innovation, the life sciences industry has sometimes been slow to embrace digital technologies like eCOA. O’Donohoe noted how this was the case particularly in comparison to some industries where technology has revolutionized the user experience, such as with banking and ride-hailing apps. We are now beginning to see how digital tools are being integrated into trial design to the significant benefit of patients. Tools such as eCOA are being used more frequently and then connected to other solutions that further enable decentralization, including wearable devices. These are transforming the patient experience of trial participation and their ability to submit data and responses without travelling to visit a trial site, and thus reducing patient burden.

Traditional clinical trials often require a sizable time commitment from patients and can be associated with significant costs and other challenges, such as travel and having to find childcare. Offering patients the flexibility to complete informed consent forms or eCOA forms through an app on their phone, and so reduce or even eliminate the need for site visits, is particularly valuable. In a session focused on the importance of patient experience in clinical research, Medidata’s Solution Consultant Brandon Steffey highlighted how reduced patient burden—and therefore better patient experiences—could lead to better data in trials. He explained how digital solutions are helping solve challenges associated with traditional clinical trials. One such tool, myMedidata, is a unified platform bringing a variety of tools together in one place for the patient, from informed consent forms prior to a trial, to eCOA and telehealth visits during a trial. These tools “bring a choice to the patient” and remove some of the burden of trial participation. Steffey pointed out that having all the information and tools available at the touch of a button can aid the patient’s understanding of the trial process; and greater awareness of what is going to happen can lead to better patient retention within trials and, therefore, better data.

Alongside patient-facing solutions, digitization has also revolutionized the way in which researchers manage trials, and importantly, the amount of data collected. As the number of complexities built into clinical trials rises, so does the burden that data places on clinical trial sponsors and organizers. Digital technologies can alleviate some of the burden by streamlining processes. As trials are collecting ever-increasing amounts of data, it’s vital for researchers to have access to tools that can help them facilitate the collection, management, and analysis of this data. Steffey explained that the unified myMedidata platform for patients can send data directly into site-facing technology solutions such as Rave EDC (electronic data capture), eliminating the need for data reconciliation and demonstrating the user-friendly interface they offer for both patients and trial organizers/managers. This continuity simplifies the process for trial organizers collecting vast amounts of data. Meanwhile, sensors worn by patients that increase the amount of real-time trial data collected can also be integrated into the myMedidata platform, while Medidata Sensor Cloud can support data collection for use in Rave EDC. These systems process data much faster than humans, allowing for better insights and an acceleration of trial operations.

Steffey summed things up perfectly, emphasizing how alleviating some of the burdens associated with trials can benefit both patients and researchers: new tools that offer flexibility to patients can lead to “better compliance, better retention, and of course better data”.