We define a decentralized clinical trial as a trial centered around patient needs that improves the patient experience. The focus of such a trial is on making it more convenient, closer to the patients, or both by using a combination of virtual and physical elements to conduct the required trial procedures.

Terminology and assumptions vary within the industry. However, a core concept remains consistent – decentralized clinical trials fall on a spectrum of conduct and components.

• Traditional clinical trials encompass little to no remote or virtual elements and are conducted exclusively at brick and mortar research sites.
• Hybrid clinical trials implement any range of decentralized, virtual, or remote components of a clinical trial.
• Full virtual or fully remote clinical trials operate as exclusively as possible outside of physical locations.

Decentralized can mean fully virtual or remote, or hybrid. No matter how you choose to approach or refer to decentralized clinical trials, it is important to understand the nuances of this evolving method and recognize their impact on the future of clinical research.

When executed intentionally and successfully, there are many operational, ethical, and regulatory benefits to conducting a decentralized clinical trial including:

• Access to wider, more geographically diverse pool of participants
• Increased participant recruitment, engagement, and retention
• Decreased burden on trial participants
• Stronger evidence package
• Efficient, centralized, and timely data collection
• Increased capacity for additional sites
• Support for future technology and process adoption to maintain research readiness

As the industry continues to adapt to remote and virtual workflows, additional benefits will be realized.