Patient Perspectives On Decentralized Clinical Trials

Clinical trials, traditionally conducted on-site, pose accessibility challenges for potential participants, limiting the representativeness of the studied population. With over 70% of U.S. potential participants residing more than two hours away from trial sites, the participant pool is significantly restricted, introducing obstacles for those willing to engage. Consider two different populations with different wants, needs, and preferences: a busy family with an ill child and an older, retired patient who has just been diagnosed with a chronic condition. The family may be more inclined to use telemedicine to accommodate their busy schedules, but an older participant with more free time may be interested in the one-to-one connection and resources that result from going to the clinic.

Despite some sponsors embracing DCTs, the industry remains cautious due to perceived barriers such as functionality, cost, return on investment, and regulatory compliance. Sites and participants also share concerns about adopting new technologies and unfamiliar methodologies. Nevertheless, DCTs offer undeniable benefits, providing access to previously inaccessible patient populations, enabling consistent information collection between clinic visits, and positively impacting study recruitment, retention, and timelines.

This position paper, although not based on original research, aims to outline the decentralized clinical trials ecosystem from the patient's viewpoint. Authored by individuals who are patients, clinical trial participants, and industry experts, their insights are informed by personal experiences. Additionally, input from the Medidata Patients Insights Board, comprising patient advocates collaborating with Medidata, enhances the perspectives presented in this paper.