Clinical Trials During the COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on clinical trials – from shutting down hundreds of trials that were to start, to redefining the parameters on subject visits, and even the suspension of clinical trials that were in place before shutting down.  The closure of sites and ability to take labs, and the move to telehealth has changed monitoring approaches.

The FDA released guidance in March for the industry, investigators and institutional review boards (IRBs) during the pandemic – with their first priority being the safety of trial subjects.   While the document is guidance, there are no enforceable rules around what a sponsor decides to do with their own trials.  The FDA created the guidance to allow for a greater flexibility – especially for those clinical trial participants who depend on the potential benefits received during a drug trial.

Yet even if a sponsor decides to amend a protocol for assessment or monitoring, IRBs may be unwilling to consider amendments during this time.  Although as recently as April 10, “the FDA's Office for Human Research Protections has issued new guidance intended to address questions regarding how the Department of Health and Human Services human subjects protection regulations apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. Among the guidance were assurances that actions taken for public health or clinical purposes, not for research, don't require institutional review board (IRB) approval before being implemented and that "investigators may implement changes to approved research prior to IRB review and approval, if the changes are necessary to eliminate apparent immediate hazards to the subject." An example of the latter would be "cancelling or postponing non-essential study visits or conducting phone visits instead of in-person visits to reduce COVID-19 transmission risks," the office said.”¹

With the availability of telehealth capabilities, providing an appropriate level of patient safety while conducting clinical trials is finally a viable option. Sponsors of those clinical trials will have to account for patients who may have had COVID-19, adjusting their endpoints as the viral effects may impact long-term outcomes and safety profiles of new therapies.

COVID-19 may also have long-term impacts on treatment outcomes in oncology because of the delay of access to care and the delay in identification of disease occurrence or relapse as patients are not being diagnosed as quickly – by either putting off appointments for early diagnosis or having biopsies and surgeries delayed due to measures in place from the pandemic. Initial feedback from providers indicates that they expect to have moderate to significant impact on patient outcomes in the next 12 months as a result of COVID-19.

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     1. https://www.bioworld.com/articles/434333-regulatory-front-for-april-10-2020