Trial Disruptions Continue to Increase in Wake of Pandemic
Sponsors, sites and regulators continue to feel the disruptive effects of the COVID-19 crisis and are scrambling to find solutions, leading to trial delays and enrollment suspensions. Here is a sampling of how some organizations are responding to the challenge:
UK Clinical Research Network Pauses Trials to Redeploy Medical Staff to Clinical Care
The UK’s National Institute for Health Research Clinical Research Network, which in 2019 supported more than 6,100 studies, is pulling back from new trial site starts to allow the nation’s research workforce to focus on providing clinical care for COVID-19 patients.
Eli Lilly Delays Trial Starts and Pauses Enrollment
The pharma giant has announced plans to cut back on its trial activities, forgoing most new starts and putting enrollment on hold in most ongoing studies. The company has advised participants already receiving treatment in a Lilly-sponsored trial to continue to follow their protocols as much as possible.
The greatest impact of Lilly’s response may be on its phase 3 trials focusing on Crohn’s disease and ulcerative colitis, which have completion dates as soon as September 2020.
Bristol Myers Squibb Sets Three-Week Delay
The drugmaker will hold new trial starts for at least three weeks, it announced last week, pushing trial initiations back to April 13 at the earliest. The company also recommended pausing early-phase trials involving healthy participants.
Pfizer Hits Pause on Enrollment
Similar to BMS, Pfizer has decided to delay enrollment in new and ongoing global trials for three weeks, with the exception of trials focused on treatments for life-threatening conditions whose participants are running out of options.
Cross-Country Delay Hits Small Biotech
Virginia-based biotech Diffusion Pharmaceuticals expects delays in completion of its phase 2 trial of ambulance-based oxygen delivery in acute stroke. The Los Angeles County Fire Department, which is participating in the trial, has suspended training of its first responders who had been scheduled to participate in the trial.
UK Venture Capital Firm Predicts Serious Delays in Its Pipeline
Syncona Investment Management, which funds trials on cancer and gene therapy treatments, expects those trials to experience at least three-month delays.
Galapagos-Gilead Partnership Holds Enrollment
Belgian drugmaker Galapagos has halted enrollment in seven mid- and late-stage studies of filgotinib, a drug being developed with Gilead Sciences to treat immune system conditions.