Balancing Clinical Care With Digital Utility In Decentralized Clinical Trials

By Dr. Graham Wylie, Medical Research Network (MRN)

As the market has been flooded with digital tech providers, the “D” in DCT is often interpreted as “digital,” rather than “decentralized.” Specifically, industry focus on developing and using novel or multipurpose digital tools occasionally leads clinical trial design to lose sight of DCTs’ underlying purpose: reducing the impact of trial burdens on patients’ lives and giving them choices in how they want to participate while maintaining their clinical care.
To create an effective DCT, available tools and methods must be considered within the context of challenges faced by the clinical trial’s patients, physicians, and sites. Through Informa, MRN collected data from 125 respondents around the world who had run DCTs, the majority of whom stated DCT tools and strategies had a positive impact on recruitment, retention, and completion timelines — primarily because the tools and methods applied reduced trial-related burdens on the patient's life. Additionally, most respondents reported the inclusion of DCT elements resulted in costs equal to or less than traditional trials. 
Accordingly, when designing a trial, it is vital to keep shared objectives (i.e., between the biopharma sponsor, its partners, and patients) in mind. Toward this end, three key objectives are at the heart of all improvements to trial delivery facilitated by DCT tools and methods:

• running the trial as quickly as safety and data accuracy permit
• ensuring high-data-quality trials through meticulous data collection and documentation
• promoting physician awareness.