Whitepaper
Is it time to go beyond classic
design in oncology trials?
Traditional first-in-human (FIH) trial designs in oncology are reaching their limits—and now, innovative sponsors are exploring a new path: enrolling healthy volunteers for certain small molecule oncology drugs. But when is this approach appropriate?
In this whitepaper, you’ll learn how emerging FIH design strategies—supported by regulatory evolution and advanced modeling—can potentially speed timelines, reduce trial burden, and better optimize dose selection. Find out how to assess when healthy volunteers may be feasible, and what conditions and safety data are required to make that call.
Key takeaways include:
- When enrolling healthy volunteers is (and isn’t) appropriate in oncology FIH trials
- How small molecule properties and preclinical data guide trial design decisions
- Key regulatory considerations from EMA and other global agencies
- The advantages of using healthy volunteers in early phase oncology studies
- Risks, limitations, and ethical factors to weigh in your FIH strategy
- How innovative trial designs are transforming early oncology development