COVID-19 vaccines and therapeutics have been developed with unprecedented speed—but this is not the norm, says a forthcoming report, Clinical Development Success Rates and Contributing Factors, 2011-2020. This morning, BIO’s VP of Industry Research David Thomas and report co-authors unveiled the report and explained what you need to know about clinical trial success in 2021.
On average, it takes 10.5 years for a phase 1 program to progress to regulatory approval.
From 2011-2020, a drug in a phase 1 clinical trial had a 7.9% likelihood of approval (LOA)—a decrease from 9.6% in the 2016 report based on data from 2006-2015.
What’s behind the decrease? Greater participation from smaller firms participating in drug candidate development and their willingness to disclose early failures, explained Thomas.
But some disease areas have higher LOAs—like hematology (23.9%), rare disease therapies (17%), and immuno-oncology (12.4%). (Interestingly, immuno-oncology drugs, such as PD-1 immune checkpoint inhibitors, were not included in the 2016 report as they were just emerging.)
Ultimately, drug development remains difficult—with far less than 1 in 10 clinical drug programs ever reaching patients. This is why success requires “many shots on goal,” concluded Thomas.
To learn more about the impact of COVID-19 on trials, the role of biomarkers, and why we’re still optimistic about drug R&D,read our preview.
Published by BIO, QLS Advisors, and Informa Pharma Intelligence, the report will be available to the public on February 19.Click here to be notified when it’s available.
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