Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations

Decentralized clinical trials (DCTs) facilitate conducting studies outside the physical boundaries of traditional clinical research facilities. They can extend the reach of clinical investigations to historically underserved populations while enabling incorporation of tools, such as digital health and telemedicine, for high-frequency remote monitoring of patients in real-world settings. DCTs require special attention to cybersecurity and data privacy protection laws and can be an efficient means of supporting a more patient-centered and inclusive clinical research enterprise.