Bookedited by Shivaani Kummar, Chris Takimoto.
Contents:
1. Changing landscape of early phase clinical trials: beyond the horizon
2. Requirements for filing an investigational new drug application
3. The evolution of phase I trials, past, present, and future: a biostatistical perspective
4. Evolving early phase trial designs: a regulatory perspective
5. The challenges of implementing multiarmed early phase oncology clinical trials
6. Designing trials for drug combinations
7. Dose selection of trageted oncology drugs in early development: time for change?
8. Integrating biomarkers in early-phase trials
9. Can early clinical trials help deliver more precise cancer care?
10. Role of imaging in early-phase trials
11. Clinical trial design in immuno-oncology
12. Cell-based therapies: a new frontier of personalized medicine
13. Incorporating patient-reported outcomes into early-phase trials
Index.