Introduction and Overview of Decentralized Clinical Trials

Clinical trial participation remains a significant challenge, with fewer than 5% of adults enrolling across all disease areas. Barriers such as geographic accessibility, financial constraints, and cultural factors impede enrollment, particularly affecting older adults, underserved racial and ethnic groups, lower socioeconomic status individuals, those with comorbidities, and rural residents. Slow recruitment extends trial timelines which lead to premature trial termination and hinder scientific advancements. The COVID-19 pandemic catalyzed the adoption of decentralized clinical trials (DCTs) to address disruptions in healthcare delivery. During this period, the industry embraced flexible approaches such as telehealth, remote monitoring, and virtualization of crucial elements. Post-pandemic, DCT methods are imperative to foster flexible trial design, participant engagement, and accelerated drug development.