Muaiad Kittaneh, Oncology R&D Executive and Independent Consultant in Global Clinical Development and Translational Strategy, shared a post on LinkedIn:
“Important read from JCO Global Oncology on the role of regional enrollment strategies in global oncology trials.
In drug development, we often talk about “global” trials but this paper thoughtfully addresses what global relevance actually requires: intentional trial design that accounts for regional standards of care, epidemiology, regulatory expectations, and access realities.
A few points that resonated with me:
- Regional enrollment isn’t just an operational decision: it’s a scientific and regulatory strategy.
- Early planning around geographic representation and inclusion can strengthen data transportability and regulatory confidence.
- More inclusive enrollment leads to evidence that better reflects the RW populations we ultimately serve.
As oncology development becomes more and more complex and more global, frameworks like this help move us beyond one-size-fits-all trials toward programs that are both rigorous, scalable and representative.
Worth the read for anyone involved in clinical development, regulatory strategy, or global trial execution.”
Title: Global Trials, Local Relevance: A Scientific and Regulatory Framework for Regional Enrollment in Cancer Drug Development
Authors: Denis Horgan, Zorana Maravic, Ken Mastris, Hadi Mohamad Abu Rasheed, Carolina Reduzzi, Adda Bounedjar, Hesham Elghazaly, Alejandro Mohar, Roberto Pestana, Jonathan A. Lal, Umberto Malapelle, Ramin Asgary, Vivek Subbiah
Read the Full Article.
More from Muaiad Kittaneh on OncoDaily.