Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology

Author:

Hobbs Brian P1,Barata Pedro C23,Kanjanapan Yada45,Paller Channing J6,Perlmutter Jane7,Pond Gregory R8,Prowell Tatiana M910,Rubin Eric H11,Seymour Lesley K12,Wages Nolan A13,Yap Timothy A14,Feltquate David15,Garrett-Mayer Elizabeth16,Grossman William1718,Hong David S14,Ivy S Percy19,Siu Lillian L4,Reeves Steven A20,Rosner Gary L21

Affiliation:

1. Quantitative Health Sciences and Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH

2. Division of Hematology and Medical Oncology, Taussig Cancer Institute Cleveland Clinic, Cleveland, OH

3. Department of Internal Medicine, Division of Hematology and Medical Oncology, Tulane University Medical School, New Orleans, LA

4. Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada

5. Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia

6. Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD

7. Gemini Group, Ann Arbor, MI

8. Department of Oncology, McMaster University, Hamilton, ON, Canada

9. Office of Hematology & Oncology Products, Food and Drug Administration, Silver Spring, MD

10. Breast Cancer Program, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD

11. Global Clinical Oncology, Merck Research Laboratories, Kenilworth, NJ

12. Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada

13. Division of Translational Research & Applied Statistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA

14. Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX

15. Early Clinical Development, Bristol-Myers Squibb, Princeton, NJ

16. Center for Research and Analytics, American Society of Clinical Oncology, Alexandria, VA

17. Cancer Immunotherapy- Global Product Development Oncology, Genentech, Inc., San Francisco, CA

18. Bellicum Inc., Brisbane, CA

19. National Cancer Institute, Cancer Therapy Evaluation Program, Rockville, MD

20. National Cancer Institute, Coordinating Center for Clinical Trials, Rockville, MD

21. Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins, Baltimore, MD

Funder

National Cancer Institute

National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

Reference87 articles.

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