Patient-facing digital technologies play an increasingly important role in the conduct of human clinical trials for new drugs and medical devices. Some say that the use of such technology will enable remote patients to participate in these ‘virtual’ or ‘decentralized’ trials, where they haven’t been able to before.
As the industry looks forward to a time when this type of technology is core to every aspect of a trial, it’s also confronted with a host of challenges. Beginning with a lack of clear agreement on what constitutes a decentralized trial, these challenges extend to technology design, implementation, data integration, data validity, regulatory acceptance, and – crucially – its effect on the patient experience.
To explore these challenges, Oracle Health Sciences, in partnership with CNS Summit, convened a series of focus groups and supplementary research with individuals representing key stakeholders in the clinical trial ecosystem. All of the participants had significant experience in both clinical trials and the use of patient-facing technologies. As far as the benefits of decentralized trials, participants described the value of technology to widen the pool of trial participants, increase retention, improve the quality of the data, and improve patient convenience.
Conversely, participants also reported on how challenges in incorporating technology have (in some ways) slowed the clinical trial process and failed to realize the full potential of “virtual components” in a trial. However, they believe that the solution lies in cross-industry efforts to standardize terminology and data models, as well as a gradual incorporation of digital endpoints and patient-facing technologies in Phase II and, later, Phase III trials. They also stressed the importance of defining areas where technology should remain only an adjunct to traditional human interaction with patients.
Oracle Health Sciences and CNS Summit are pleased to share the results of this research with our colleagues in the industry. We hope this report will provide the foundation for an industry-wide effort to redefine what constitutes a decentralized clinical trial, and in turn help remove barriers to the effective use of patient-facing technologies and digital endpoints in the future.