Although consolidation and rapid accrual may yield efficiencies, widespread use of seamless first-in-human (FiH) trials without careful consideration of objectives, statistical analysis plans, or trial oversight raises concerns. Innovations in drug development seek to consolidate the phases and rapidly expand accrual with "seamless" trial designs. Traditionally, drug development has evaluated dose, safety, activity, and comparative benefit in a sequence of phases using trial designs and endpoints specifically devised for each phase. 21 Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins, Baltimore, MD.20 National Cancer Institute, Coordinating Center for Clinical Trials, Rockville, MD.19 National Cancer Institute, Cancer Therapy Evaluation Program, Rockville, MD.17 Cancer Immunotherapy- Global Product Development Oncology, Genentech, Inc., San Francisco, CA.16 Center for Research and Analytics, American Society of Clinical Oncology, Alexandria, VA.15 Early Clinical Development, Bristol-Myers Squibb, Princeton, NJ.14 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX.13 Division of Translational Research & Applied Statistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA.12 Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada. ![]()
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