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...
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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.
Bibliographische Angaben
- Herausgegeben:Kummar, Shivaani; Takimoto, Chris
- Verlag: Academic Press
- EAN: 9780128125120
Autoren-Porträt
Upon completing her medical degree from Lady Hardinge Medical College in New Delhi, India, Shivaani Kummar moved to the United States to train in Internal Medicine at Emory University in Atlanta, Georgia. Following this Kummar was selected to pursue fellowship training at the National Institute of Health (NIH) in Medical Oncology and Hematology, which culminated in being offered a faculty position at Yale University, New Haven CT. After spending four years as Assistant Professor of Medicine at Yale Cancer Center, she moved back to the National Cancer Institute (NCI), NIH, where she developed a clinical research program in novel cancer therapeutics. In 2011 she became Head of Early Clinical Trials Development in the Office of the Director, Division of Cancer Treatment and Diagnosis, NCI. Kummar moved to Stanford University in 2015 as Professor of Medicine and Director of the Phase I Clinical Research Program. Kummar's research interests focus on developing novel therapies for cancer. She specializes in conducting pharmacokinetic and pharmacodynamic driven first-in-human trials tailored to make early, informed decisions regarding the suitability of novel molecular agents for further clinical investigation. Kummar is the principal investigator of numerous early phase trials, and serves on multiple national and international scientific committees.
Inhaltsverzeichnis zu „Novel Designs of Early Phase Trials for Cancer Therapeutics “
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
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