COVID-19 and the Threat to Clinical Trials

TRP partners Beau Schuyler and Andrew Rosenberg have identified a little-discussed downstream consequence of the COVID-19 pandemic – the impact on clinical trials and the potential for disruption or cancellation of important drug discovery programs absent federal action.

As the world struggles with the immediate health and economic havoc caused by COVID-19, forward-looking policy makers would be wise to anticipate and mitigate some of the longer-term damage being done to the public health. And while the pandemic is certain to affect global health in a variety of unexpected ways, one predictable outcome that we are already witnessing is COVID’s highly deleterious impact on the search for unrelated cures in the form of large-scale clinical trial disruption.

During the past several months, an increasing number of health care journalists and biopharma executives have highlighted how drug manufacturers are delaying the start of new clinical trials, and that current trials are taking longer and proving more difficult to complete. Of course, the reasons for these disruptions are very understandable: stay-at-home orders, new hospital guidelines, patient concerns about exposure to COVID-19 at the point of care, and the logistical challenges associated with traveling to trial locations. 

While most experts expect drug innovators to find ways to continue the majority of currently planned clinical trials, the financial impact of these delays and complications could be catastrophic to some programs, especially those aimed at curing rare and pediatric diseases where the endeavor’s financial footing is weakest. This dynamic, coupled with the resulting reduction in a new product’s patent life, looms particularly daunting for venture-backed, upstart companies looking to launch their first product. For patients and parents praying for new therapies, this could mean crushing disappointment in the form of canceled or delayed trials or even entire drug development programs.   

Policymakers and healthcare professionals are rightly prioritizing the immediate crisis in front of us. However, as the nation begins to reopen and political leaders start the process of addressing unmet future needs, we should ensure the protection of our innovation pipeline by ensuring that COVID-19 doesn’t eviscerate the economics of a generation of promising new medicines.