Nicholas Hornstein/X
Jun 19, 2025, 09:48
Nicholas Hornstein: Watching the Center of Gravity in Oncology Drug Development Move
Nicholas Hornstein, Assistant Professor at Northwell Health, shared a post on X:
“Had a conversation with someone outside of healthcare recently who was shocked by how long it takes to run clinical trials in the U.S (not to mention expensive).
I tried to explain – it’s not just the science. It’s the infrastructure. Every site needs dozens of personnel, many of whom are required by regulatory frameworks that – while important – haven’t kept pace with the speed of innovation. Startup time? Often, 3- 6+ months before a single patient is enrolled.
Meanwhile…
In the past 5 years, China launched 84 novel oncology drugs – nearly matching the U.S. (85) – after trailing far behind just a decade ago.
China-headquartered companies now account for 39% of global oncology trial starts – up from only 5% in 2013. Over the same period, the U.S. share has declined to 32%.
We’re not just seeing a geographic shift – we’re watching the center of gravity in oncology drug development move.
Regulatory teams play a critical role in ensuring patient safety and scientific rigor. But to keep up, we need systems that allow them to focus on those essential responsibilities – rather than duplicative paperwork and fragmented startup processes.
Smarter regulation, shared infrastructure, and less reinvention of the wheel at every site could help us retain leadership in global drug development.”
Razelle Kurzrock, Founding Director of Michels Rare Cancers Research Laboratories and Professor of Medicine at Medical College of Wisconsin, shared this post, adding:
“Important.
It’s also the way studies are done. Same templates as 50 yrs ago, but with 1000x paperwork.Rule N1: A bureaucracy once instituted is resistant to rollback.
Comment: all new bureaucracies/committees are started under the pretext of making things better/more efficient.”
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