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The Impact of COVID-19 on the Regulatory Landscape

Lessons learned from a Virtual Town Hall held on April 10, 2020

The impact of COVID-19 on trial conduct and the regulatory landscape is rapidly changing, requiring continuous attention and adaptation.  According to WCG’s Knowledge BaseTM Insights from 10 April 2020, 100+ non-COVID-19 trials had been put on official hold, and only 14% of sites are open for enrollment.  Stats like this demand that we evaluate the regulatory impacts our industry faces in the wake of COVID-19 and what to expect in the months ahead.

On April 10, 2020, as part of Halloran’s Virtual Town Hall series, Halloran convened a panel of experts to discuss what our network is seeing in terms of regulatory activity as some cases warranted and received expedited feedback, while others are seeing delays to reviews and receipt of commentary from the U.S. Food and Drug Administration (FDA).  Specifically, there was discussion around the institutional review board (IRB) review prioritization rationale, regulatory CMC programs, ancillary functions, and more.  Below are some key insights from the panel’s experience conducting regulatory activities during the pandemic.

Impact to FDA meetings and reviews

COVID-19 Programs

Impact to ancillary functions that support clinical trials

Impact to Regulatory CMC programs

General regulatory considerations


When considering the regulatory obstacles around starting/conducting clinical trials during a pandemic, sponsors should think beyond the IND – is it feasible to conduct a clinical trial at this time?  Is it possible to wait until health authorities aren’t so heavily burdened and sites are running at normal capacity?  Resource shortages, remote monitoring, and protocol amendments are some of the many factors complicating the regulatory landscape right now.  We can expect an activity backlog to build over the next few months, which is another reason to limit submissions as much is feasible for non-life-threatening conditions.  Thoughtful delays for some noncritical programs could significantly lighten the load for our reviewers, and hopefully, make the return to normalcy easier when the time comes.