Title: Statement on P-values.
Authors: Gwise, Thomas; Rothmann, Mark D.; James Hung, H.M.; Amatya, Anup; Rothwell, Rebecca; Wang, Sue Jane; Wu, Yute; Smith, Fraser; Weng, Yu-Ting; Andraca-Carrera, Eugenio; Grosser, Stella; Chattopadhyay, Somesh; Collins, Sylva H.
Abstract: We briefly outline how past and current use of I p i -values by the Center for Drug Evaluation and Research (CDER) in FDA is aligned with good scientific principles and point out how our organization eschews the most egregious I p i -value missteps. We briefly review the I p i -value's definition and discuss how CDER's use of I p i -values is aligned with responsible statistical and scientific principles. While there are examples of I p i -value misuse in other settings, CDER's use of I p i -values generally aligns with principles set out by thought leaders in the field.
Subjects: STATISTICAL hypothesis testing; PROGRESSION-free survival; FALSE positive error; SOCIAL psychology
Publication: Statistics in Biopharmaceutical Research, 2021, Vol 13, Issue 1, p57
ISSN: 1946-6315
Publication type: Academic Journal
DOI: 10.1080/19466315.2021.1886164

Statement on P-values.

Gwise, Thomas; Rothmann, Mark D.; James Hung, H.M.; Amatya, Anup; Rothwell, Rebecca; Wang, Sue Jane; Wu, Yute; Smith, Fraser; Weng, Yu-Ting; Andraca-Carrera, Eugenio; Grosser, Stella; Chattopadhyay, Somesh; Collins, Sylva H.