Novel Designs of Early Phase Trials for Cancer Therapeutics

Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials.

This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials.

Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeuticsProvides the reader with a better understanding on how to design and implement early phase oncology trialsPresents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Introduction: Changing landscape of phase I trials 1. Phase I trial designs: Past, Present, and Future 2. Statistical perspectives on cohort expansions in early phase trials 3. Determining the optimal dose and schedule 4. Conducting large phase I trials with multiple expansion cohorts 5. Role and application of molecular profiling in early phase trials 6. Novel trial designs for immunotherapies 7. Designing trials for cell based therapies 8. Evaluating novel drug combinations in early phase trials 9. Integrating biomarkers in early phase trials: developing the evidence base for ‘actionable’ biomarkers 10. Novel imaging endpoints in early phase trials 11. Developing a novel agent: the regulatory process perspective 12. Conducting proof of concept phase I trials-Regulatory Implications 13. Efficacy endpoints in early phase trials 14. Incorporation of Patient Reported Outcomes in early phase trials