FDA Guidance for Trials in Pandemic Hints that Virtual Clinical Trials Are Least Affected
​​[Thursday, March 19, 2020]
​Most ongoing clinical trials in the US have been suspended indefinitely, and no new trials are being initiated due to the COVID-19 pandemic. FDA advices measures like those implemented during a temporary clinical hold in such circumstances. With shelter at home advisory and mandatory quarantine in place in most places in the country, clinics must restrict their operations to critical functions only. It is also possible that study staff are unavailable and non-essential staff have been directed to stay in self-quarantine. Most clinical trial staff would be considered non-essential by clinics. In such situation, sponsors should implement measures planned for temporary clinical hold. Patient safety should always be the first concern so trial supplies to participants and adverse event management should continue. The investigational drugs can be delivered to the patient’s home, but study related tests and clinical assessments are likely affected. Sponsors could employ alternate means for collecting study specific data such as phone contact, online tools to collect information, and alternate locations for blood draws or other assessments provided it is allowed by the study protocol. The study dropout rates may spike as patients decide to discontinue or become lost of follow-up. Sponsors should decide if continuing a patient on the study treatment is in the patient’s best interest. Although FDA does not explicitly say in the Guidance Document, it hints that it may be better to suspend the study recruitment temporarily, while focusing on finding ways to manage the continuity of the patients already enrolled. Virtual clinical trials that already employed remote visits, mobile monitoring technologies using wearable devices, and digital endpoints are least affected by the pandemic. Since the biggest impact on clinical trial continuity is due to the restricted access to sites, physical contact with personnel, and travel restrictions, virtual clinical trials are at an advantage since they anyway don’t involve much of either of these. As the pandemic prolongs, the impact on ongoing clinical trials will increase exponentially. Sponsors may need to amend the protocols, revise statistical plans to deal with missing data points, find ways to address deviations, and even decide to suspend or terminate the study, if efforts to continue become unreasonable. So far, we are far from that doomsday scenario, but we should be prepared. The pandemic emphasized the importance of virtual clinical trials using new technologies over conventional methods and should boost the use of these even after the pandemic is over.