Elena Levi-D’Ancona, Science Policy Analyst at Friends of Cancer Research, shared on LinkedIn:
“Ahead of our 2026 Annual Meeting, Friends of Cancer Research released three white papers focused on modernizing early-phase oncology drug development while maintaining patient safety. I’m excited to share one of these papers, which I had the opportunity to lead alongside a multidisciplinary working group.
Our paper explores how a more risk-based, fit-for-purpose approach to first-in-human (FIH) oncology studies could support more efficient and predictable clinical development. Uncertainty around evidence expectations across different stages of development can lead to interactions with FDA that aren’t actionable, avoidable protocol amendments, and delay.
The working group identified four opportunities to modernize FIH expectations:
- Aligning evidence with initial protocol objectives: Tailoring expectations to study objectives, product characteristics, and potential risks.
- Improving pre-IND interactions: Using the appropriate FDA engagement mechanism to obtain actionable feedback.
- Strengthening risk-based approaches: Considering available evidence, uncertainties, and appropriate safeguards to inform product-specific decisions.
- Minimizing operational disruptions: Better aligning study start-up activities with regulatory interactions to reduce avoidable delays.
Ultimately, modernizing FIH expectations is not about lowering evidentiary standards or compromising patient safety, but ensuring that evidence requirements are scientifically justified and fit-for-purpose.
A big thank you to all the working group members for their thoughtful contributions, expertise, and collaboration throughout this process: Clay Alspach, Laleh Amiri, Imein Bousnina, Kathryn Bradford, Simon Burns, Lyn Chen, Lindsay Cobbs, Ilaria Conti, Myrtle D., Darcy Denner, Ulf Forssmann, R. Donald Harvey, Kyle Holen, David S. Hong, Emily Hsiue, Michael Kalos, Tamy Kim, Kristine Koontz, Shaliny Kushwaha, Rosalida Leone, Kristin McJunkins, Funda Meric-Bernstam, Briggs Morrison, Joanna Pols, Arnoldo Rodriguez, Susan Rouse, Nirali Shah, Harpreet Singh, Mark Stewart, Maria Cecilia Tami, Stacey Tinianov, Donghua Yin, Sunita Zalani.
You can also read: Ari Gnanasakthy: China’s Growing Role in Early-Phase Oncology Drug Development