Virtual clinical trials and digital health technology
By far, the biggest innovation emerging from the COVID‐19 crisis is the virtualization of many aspects of clinical trials by digital enablement. By utilizing various digital health technologies, patients can participate in one or more aspects of a trial without visiting a clinical site as part of “routine” drug development. We commend the regulators for developing much needed guidance during the pandemic, allowing for remote monitoring and other alternatives to help sponsors continue to conduct trials. While decentralized clinical trials and digital health technologies have been critical during the current pandemic, the increased use of telemedicine creates opportunities to reform the clinical trial paradigm by implementing digitally enabled tools in areas such as patient screening, informed consent, telemedicine‐facilitated visits, and remote monitoring. The International Council for Harmonization (ICH) is currently revising the E6 Guideline Good Clinical Practice, and we believe this is an ideal opportunity to support the development of a responsive guideline with stakeholders’ perspectives and advances in technology. 7