In addition, numerous vendors offer virtualization solutions within the clinical trial administration phase, which includes trial operational management, direct-to-patient drug and supply logistics, patient treatment management, digital biomarker collection, patient and outcome data management, and real-world evidence-based synthetic control arms. To conduct a virtual or hybrid trial within the COVID-19 pandemic and beyond, sponsors must leverage an integrated set of virtualization solutions that allow for remote patient-investigator interactions, monitoring of patient safety and outcomes, and seamless management of all trial data without loss of data integrity. Notable solutions that can help sponsors achieve this level of virtualization include remote monitoring solutions, telemedicine platforms, in-home treatment and/or testing, eSource integration of all trial data and remote data capture solutions (e.g., direct data capture, eCOA, ePRO and digital biomarker collection).
None of these options would be feasible without regulatory support. Fortunately, the FDA has acted quickly to issue guidance for how COVID-19 will affect clinical trials and has noted increased flexibility around several factors, including protocol design and review, eConsent, trial operational management, direct-to-patient drug and supply logistics, and patient treatment management. Specifically, the FDA has outlined that it will now:
- Allow consolidation of protocol modifications into one protocol amendment
- Encourage sponsors to use novel mechanisms to gather consent (including via eConsent)
- Promote remote monitoring and delivery of trial drugs directly to patients’ homes
- Allow immediate implementation of protocol changes that incorporate telephone and/or virtual visits for safety monitoring
As the FDA recognizes elements of virtual clinical trial development and administration, sponsors can confidently harness virtualization solutions for current and future trials, lessening the impact of COVID-19 and making trials more efficient and patient-centric moving forward. These changes offer potentially meaningful and material benefits for both sponsors and patients beyond the context of COVID-19. Virtual visits reduce patient travel, saving significant time for the ~70% of trial participants that live at least two hours away from trial sites. Furthermore, patient drop-out rates decrease in virtual trial settings. Beyond patient retention, remote patient monitoring not only increases patient safety by allowing investigators to immediately and quickly identify safety concerns and modify trials but also provides the opportunity to diversify trial populations. Finally, hybrid or virtual trials can decrease trial expenses by diminishing costs associated with sites and site monitors and by converting in-person visits to virtual visits.