The future of clinical trials-is it virtual?

Abstract

Introduction: Participant recruitment to clinical trials is often sub-optimal. Decentralized clinical trials have the potential to address challenges in traditional site-based clinical trial recruitment.

Sources of data: This review is based on recently published literature and the experience of running a large industry-sponsored interventional trial using both traditional and decentralized methods.

Areas of agreement: Efficient delivery of clinical trials is essential to continue to provide therapeutic improvements in a timely and cost-efficient way. Clinical trial designs are constantly evolving to achieve effective trial delivery, manage the complexity of new therapeutic algorithms and conform to cultural developments.

Areas of controversy: Digitally innovative decentralized clinical trials may be a solution to improve recruitment and retention. Although many trials incorporate digital innovations to reduce patient burden, decentralized clinical trials allow remote access to clinical research, potentially enhancing geographical diversity as well as reducing participant burden.

Growing points: Areas for development currently being discussed are developing a 'recruitment platform' that exploits the reach of digital connectivity, automated identification of eligible participants from volunteers, employing technology for remote interaction and exploring the logistic process of delivering the interventions.

Areas timely for relevant research: The focus of development must ensure that the overall impact will widen participation and reduce inequalities in healthcare.