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Analysis of Safety Data of Drug Trials : an Update by Ton J. Cleophas, Aeilko H. Zwinderman is a nonfiction available to read on EtoBox.

What is Analysis of Safety Data of Drug Trials : an Update about?

In 2010, the 5th edition of the textbook, "Statistics Applied to Clinical Studies", was published by Springer and since then has been widely distributed. The primary object of clinical trials of new drugs is to demonstrate efficacy rather than safety. However, a trial in humans which does not adequately address safety is unethical, while the assessment of safety variables is an important element of the trial. An effective approach is to present summaries of the prevalence of adverse effects and their 95% confidence intervals. In order to estimate the probability that the differences between treatment and control group occurred merely by chance, a statistical test can be performed. In the past few years, this pretty crude method has been supplemented and sometimes, replaced with more sophisticated and better sensitive methodologies, based on machine learning clusters and networks, and multivariate analyses. As a result, it is time that an updated version of safety data analysis was published. The issue of __dependency__ also needs to be addressed. Adverse effects may be either dependent or independent of the main outcome. For example, an adverse effect of alpha blockers is dizziness

Who reads Analysis of Safety Data of Drug Trials : an Update?

Author

Ton J. Cleophas, Aeilko H. Zwinderman

Publisher

Springer International Publishing Imprint,Springer

Published

2019

Language

EN

ISBN

9783030058043

Category

nonfiction

Subjects

Medical, Mathematics, Medicine