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Volume 7, Issue 5 (Suppl) J Clin Trials, an open access journal
ISSN:2167-0870 Clinical Trials 2017
September 11-13, 2017
September 11-13, 2017 San Antonio, USA
4th International Conference on
Cl inical Tr ial s
A new class of distribution-free models in analysis of adverse events in drug safety
Richard Entsuah
Merck Research Laboratories, USA
In the area of pharmaceutical drug safety, one of the primary goals in analysis of adverse events (AEs) is to detect any signal
of a difference between the treatment and control groups. Traditionally, crude incidence rate, chi-square test or Fisher's exact
test, and Miettinen and Nurminen are the useful methods in analysis of single AE data depending on what level of importance
it belongs to, such as Tier 1, Tier 2, or Tier 3, which were defined by Merck. Actually, the occurrence of AEs is very complicated.
Simple measurement of AE data without enough information including duration effect, severity effect, or recurrent event,
the estimation and inference could be biased. Moreover, multiple AEs within the same system organ class (SOC) are usually
correlated with each other. So analysis of single AE over simplifies comparison among treatment arms in drug safety. In this
presentation, we would like to propose a new class of distribution-free approaches to address the effects of duration, severity,
and recurrence of AE data by using a new measurement within certain specified class. The good asymptotic properties and
robustness for the proposed models have been shown in this study. The numerical simulation studies and a case study example
are provided for illustrations.
Biography
Richard Entsuah is a Fellow of the American Statistical Association. He completed his PhD from University of Michigan. He was an Assistant Professor of Biometry
at University of Illinois in Chicago. He joined Wyeth Research from 1988 to 2007 and left as an Assistant Vice President of Global Biostatistics and Programming.
He joined Merck Research Labs as Executive Director of Late Development Statistics and is the Research Group 4 Head for Neuroscience and Respiratory
Immunology.
Richard Entsuah, J Clin Trials 2017, 7:5 (Suppl)
DOI: 10.4172/2167-0870-C1-019