Lilly delays new clinical trials, enrollments as Covid-19 bogs down study sites

The drugmaker said it would delay new study starts and also enrollments in ongoing studies due to the strain the pandemic is putting on clinical trial sites. However, patients already enrolled in trials can continue treatment. Bristol-Myers Squibb said it would continue to assess trial operations.

Clinical trials, research, drug trials

A major drugmaker plans to hold off on starting new clinical trials and enrolling new patients in ongoing ones as the Covid-19 pandemic has forced sites to shift their focus.

Indianapolis-based Eli Lilly said Monday that it would nevertheless continue ongoing clinical trials for those patients who are already enrolled. Many healthcare systems, the company said, have been forced to restructure their operations and prioritize patients with Covid-19 while limiting or halting other activities due to the burden the pandemic has placed on them.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

“Lilly is working hard to alleviate some of the pressure that the global Covid-19 pandemic has placed on our healthcare system,” Lilly chief medical officer Tim Garnett said in a statement. “We have repurposed our laboratories to conduct diagnostic testing for patients, and we are researching potential therapeutics. In the interest of helping to ensure patient safety and minimizing further stress on the system, Lilly has also decided to take several proactive steps in regard to our clinical trial activities around the world during the Covid-19 pandemic.”

The database lists 100 studies of which Lilly is the main sponsor that are recruiting participants or have not yet opened for recruitment.

Another company, New York-based Bristol-Myers Squibb, said Saturday that it would “continue to assess” the operations of its clinical trials and was taking proactive steps to protect the safety of those involved.

The global pandemic has significantly disrupted clinical trial operations, including in the U.S. Last week, an official from Northwell Health, which runs several hospitals and clinics in New York and its surrounding suburbs, said in a virtual press conference that the trial of a drug under investigation as a treatment for the SARS-CoV-2 virus was able to get up and running in only four days rather than the months it would otherwise take because other clinical trial activities had been put on hold. Meanwhile, a survey of more than 100 clinical trial sites in the U.S. by Continuum Clinical found that around one-third of respondents expect the pandemic to have significant effects on their ability to recruit patients into new trials or retain those already enrolled. An investment bank analyst expressed similar concerns, with academic centers preparing for a surge in Covid-19 patients, creating risks for existing trials’ execution. The FDA issued a guidance outlining ways that trials could go virtual.

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