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Potential Statistical Issues Between Designers and Regulators in Confirmatory Basket, Umbrella, and Platform Trials
Author(s) -
Berry Scott M.
Publication year - 2020
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1908
Subject(s) - clinical trial , drug development , data science , computer science , drug approval , drug trial , risk analysis (engineering) , medicine , management science , engineering , pharmacology , drug , pathology
Platform and basket trial have the potential to alter the landscape of drug development in many disease areas. Although these trials create many efficiencies compared with simple trials, they also create new statistical challenges for regulators. I highlight some of these new issues and discuss the regulatory challenges emerging from these trials. I highlight some critical points made by Collignon et al ., 1 while providing some conflicting views on these statistical challenges.