Journal article
Semi-blinded design in clinical trials
Abstract
The semi-blinded design can be applied for the adaptive design in clinical trials. According the the FDA guidance, an adaptive clinical design study would modify the study design and hypotheses based on the analysis of accrued data. An independent Data Monitoring Committee analyzes the unblinded data in the middle of a clinical trial and makes recommendations to the sponsor if any action is needed. The unblinded interim analysis could …
Authors
Wan S-M; Balakrishnan N; Manurung MM; Chang K-H; Wu C-H
Journal
Communication in Statistics- Theory and Methods, Vol. 52, No. 20, pp. 7165–7183
Publisher
Taylor & Francis
Publication Date
October 18, 2023
DOI
10.1080/03610926.2022.2042024
ISSN
0361-0926