Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
⇒View Archives here⇐
Organizing Committee:
Faculty from UMBC and Stanford University and leaders from FDA and industry.
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Ming Tan from Georgetown University Medical Center/Lombardi CCC.
Paper: Robust Estimates of Regional Treatment Effects in MRCT via Semi-Parametric Modeling
Multiregional randomized clinical trials (MRCT) are increasingly common. Despite of randomization, there may be a differential treatment effect among different regions, potentially due to confounding region specific factors. Most current methods for the assessment of the consistency or similarity of the treatment effect between different ethnic groups based on some subjectively specified model. We propose a novel semi-parametric model and show that it can give robust estimates of the regional treatment effects. The model is estimated by maximizing profile likelihood using EM. The profile likelihood ratio statistic is used to test the existence of regional differences. We derived the asymptotic properties of the estimate and show that semiparametric model performs well by simulation. We then discuss applications to two clinical trials.