Publications by authors named "Satoru Fukimbara"
Background: Two issues on clinical trials with multiple endpoints were surveyed: (1) the terminology of multiple endpoints, relationship between rare events and endpoints, and differences in multiplicity adjustment between regions; and (2) the current practice on multiplicity adjustment and sample size calculation. This article provides a summary of the results of a survey on the first issue.
Methods: The survey was conducted among 63 members of the Japan Pharmaceutical Manufacturers Association from October to November 2017.
Background: Two issues in clinical trials with multiple endpoints were surveyed: (1) the terminology of multiple endpoints, the relationship between rare events and endpoints, and the differences in multiplicity adjustment between regions, and (2) the current practice on multiplicity adjustment and sample size calculation. This article summarizes the results of the survey on the second issue.
Methods: Eligible trials for this survey fulfilled the following conditions: (1) confirmatory phase 3 trial; (2) use of multiple primary endpoints, co-primary endpoints, key secondary endpoint(s) or composite endpoint(s); (3) inclusion of Japanese participants; and (4) protocols created in 2010 or later.
Background: Two issues on clinical trials with multiple endpoints were surveyed: (1) the terminology of multiple endpoints, relationship between rare events and endpoints, and differences in multiplicity adjustment between regions; and (2) the current practice on multiplicity adjustment and sample size calculation. This article provides a summary of the results of a survey on the first issue.
Methods: The survey was conducted among 63 members of the Japan Pharmaceutical Manufacturers Association from October to November 2017.
Background/aim: Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials.
View Article and Find Full Text PDFBackground: To confirm the effectiveness of sivelestat, a clinical trial was conducted comparing sivelestat with conventional treatment in an open, nonrandomized, multicenter study of patients with systemic inflammatory response syndrome (SIRS)-associated acute lung injury. The primary endpoint was ventilator-free days (VFD).
Methods: This study adopted a "cluster entry" method to control for patient selection bias arising from the unblinded and nonrandomized clinical trial.
Background: This study provides the results of a survey on the current practice of multiplicity adjustment and sample size calculation in multi-arm clinical trials.
Methods: The survey was aimed at members of the Japan Pharmaceutical Manufacturers Association (JPMA) and was conducted in 2015.
Results: Of the 66 JPMA member companies, effective responses were obtained on 151 trials from 33 companies based in Japan and 11 companies based in other countries.