Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation

Ionan, AC; Paterniti, M; Mehrotra, DV; Scott, J; Ratitch, B; Collins, S; Gomatam, S; Nie, L; Rufibach, K; Bretz, F

Ionan, AC (通讯作者)，US FDA, Ctr Drug Evaluat & Res, WO21 Room 3654,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.

STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2023; 15 (3): 554

Abstract

The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials (Step 4) was finalized in November 2019 and subsequently implemented......

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