COVID-19 to delay clinical trials

Big drug companies and biotech firms are working overtime on therapies and vaccines aimed at stopping COVID-19. At the same time, these companies are struggling, amidst social distancing and the diversion of clinical resources, to keep clinical trials going for the rest of their therapeutic pipelines.

Eli Lilly and Company’s stated strategy is typical of big pharma. The firm says it will delay the start of most new studies and pause enrollment in most ongoing studies. Lilly will continue ongoing clinical trials for people who are already enrolled.

“By delaying most new study starts and pausing enrollment of new patients or healthy volunteers in most ongoing studies, we hope to ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combating COVID-19,” Tim Garnett, Lilly’s chief medical officer, says in a statement. “We will maintain ongoing studies, but with study-by-study consideration.”

Amgen says it has paused enrollment in clinical trials when the ability of testing sites is uncertain. The firm is continuing enrollment in studies where site resources allow and where it sees the potential for benefit in a serious or life-threatening condition. For example, the company says a trial of AMG 510, a closely watched KRAS inhibitor for lung cancer, is fully enrolled and that it does not anticipate significant delays in obtaining results.

Stock analysts who follow the biotech industry acknowledge corporate optimism but say they expect disruption even in ongoing trials. In a note to clients, analysts at SVB Leerink cited experts who say trial recruitment in the New York metropolitan area is practically halted and that data from ongoing studies will likely diverge from protocols.

Leerink noted that executives at BioNTech, a German biotech firm developing a coronavirus vaccine as well as various cancer treatments, said on a recent investor call that they expect 3–6 month delays in receiving results from some clinical trials. “COVID-19 will likely pause or disrupt clinical trial progress,” the analysts concluded, “but most companies will endure.”