Eli Lilly and Co. plans to delay the start of most planned new studies and pause enrollment in most of its studies that are ongoing. However, the company intends to continue currently occurring trials for already enrolled patients.
The company states the global coronavirus/COVID-19 has had a tremendous impact on the global healthcare system, including clinical trial operations. The majority of healthcare systems have had to make changes to their operations during the pandemic, including prioritizing care for coronavirus patients and limiting or stopping other functions.
The impacts of the virus also have impaired the ability of research sites to maintain its previous level of activity on studies, start new studies, or enroll new patients to trials.
According to Tim Garnett, chief medical officer for Lilly, the company is doing its best to relieve some of the pressure the coronavirus has placed on healthcare infrastructure around the world.
“We have repurposed our laboratories to conduct diagnostic testing for patients and we are researching potential therapeutics,” he said. “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 combatting COVID-19."
Garnett added that while stopping enrollment of new patients will help ease the burden on the healthcare system, disrupting the activity of enrolled patients could be detrimental.
“Lilly recognizes that for patients already enrolled in clinical trials, discontinuation would disrupt their treatment and potentially diminish the societal value of the research information to which they are contributing. Therefore, we will maintain ongoing studies, but with study-by-study consideration," he said.
The company advises that study participants currently enrolled and continuing with trials should continue to follow the protocols of their studies, and to speak with their physicians about any lingering concerns they may have about participation.