When the U.S. formed Operation Warp Speed toward the beginning of the COVID-19 pandemic last spring, drug developers, clinical research organizations and other players felt the weight behind the initiative’s urgent name.
The pandemic forced CROs like IQVIA to rethink and boost resources, because the “clear traditional timelines would not be sufficient” to get COVID-19 vaccines to the public quickly, the company said in a new report. Vaccine development can take 10 to 15 years, but that would not suffice for a world that wanted and needed to get through a pandemic that has left millions dead.
COVID-19 vaccine clinical trials ramped up quickly in spring 2020, going from about 10 in March 2020 to nearly 25 by June of that year, according to research released last week from GlobalData’s Pharma Intelligence Center. The number of trials has not slowed down as the need to vaccinate more than 7 billion people requires a hefty amount of sites. The number peaked at 89 trials this March, GlobalData said.
At the beginning of the pandemic, the pace of vaccine trials was actually overshadowed by COVID-19 therapeutics, as the need for treatment options surged. There were nearly 450 therapeutic clinical trials by April 2020, but that number fell sharply to less than 100 by March 2021.
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“The upward trend for vaccine COVID-19 clinical trials is expected to continue due to the same approved vaccines testing against new variants of the virus,” said Scotty Chung-Siu, senior analyst at GlobalData, in a statement. "On the other hand, the decrease in therapeutic COVID-19 clinical trials may be due to the increase in availability of vaccines as well as the negative data in clinical trials from some therapeutics, such as hydroxychloroquine."
Last April, IQVIA hit the ground running with a COVID-19 trial matching tool and an opt-in registry open to anyone for shared information about the disease, symptom progression and treatment outcomes. Three months later, the company said it was collaborating with AstraZeneca on the Big Pharma’s COVID-19 vaccine as part of Warp Speed.
With the challenge of rapidly launching studies, IQVIA had to partner with regulatory review company Advarra to handle institutional biosafety committee (IBC) and institutional review board processes to meet the pressing need.
Advarra supported all of the Warp Speed vaccine clinical trials, the company said, and, as of last week, claims to be the largest administrator of IBCs with more than 500 registered research sites. IBC approval times for the vaccine trials shrank to less than two working days, the company said in a case study.
With Advarra’s speed, IQVIA sites were able to average 78% faster approval than non-COVID sites, which took a hit from health and safety measures meant to prevent the spread of the virus that caused a delay in many trials. IQVIA’s sites were also activated to “ready to enroll” status 71% faster than non-COVID sites.
Clinical trials, in general, have gotten a reboot through new means of administration with an influx of virtual, or “siteless” trial companies, like Medable, Science 37 and Curebase.