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Analysis of Safety Data of Drug Trials

An Update

  • Ton J. Cleophas
  • Aeilko H. Zwinderman

Table of contents

  1. Front Matter
    Pages i-xi
  2. Ton J. Cleophas, Aeilko H. Zwinderman
    Pages 1-19
  3. The Analysis of Independent Adverse Effects

    1. Front Matter
      Pages 21-21
    2. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 23-66
    3. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 81-93
    4. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 95-102
    5. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 103-118
    6. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 119-127
    7. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 129-134
    8. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 135-143
  4. The Analysis of Dependent Adverse Effects

    1. Front Matter
      Pages 145-145
    2. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 147-157
    3. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 159-165
    4. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 167-174
    5. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 175-181
    6. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 183-193
    7. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 195-202
    8. Ton J. Cleophas, Aeilko H. Zwinderman
      Pages 203-214
  5. Back Matter
    Pages 215-217

About this book

Introduction

The authors, as professors in statistics at various universities in Europe, are worrried about the poor quality of safety data analysis of clinical trials, despite its importance in drug development and pharmacovigilance.

Clinical trials, not adequately addressing safety, are unethical. An effective approach for the purpose is to present summaries of prevalences. In order to estimate the probability, that the differences between treatment and control group did not occur merely by chance, a statistical test can be performed. This pretty crude method has recently be supplemented with better sensitive methodologies, based on machine learning clusters and networks, and multivariate analyses.

Another important novelty with safety data analysis is the new insights into hypothesis testing, favoring the alternative hypotheses instead of the null hypotheses.

Finally the issue of dependency is addressed. Adverse effects may be either dependent or independent of the main outcome. Dependent adverse effect are dependent not only on the treatment modalities, but also on the outcome of the trials. Random heterogeneities, outliers, confounders, interaction factors are common in clinical trials, and all of them can be considered kinds of adverse effects of the dependent type. Random regressions and analyses of variance, high dimensional clusterings, partial correlations, structural equations models, and other Bayesian methods are helpful for their analysis. 

The current edition was particularly written for medical and health professionals and students. It provides examples of modern analytic methods so far largely unused. All of the 16 chapters have two core characteristics, first they are for current usage, second they try and tell what readers need to know in order to understand the methods. Step by step analyses are given and self-assessment examples are supplied. Each chapter can be studied as a stand-alone.

Keywords

Safety Data Drug Trials Statistical Analysis Dependent Adverse Effects Random Effects Analysis

Authors and affiliations

  • Ton J. Cleophas
    • 1
  • Aeilko H. Zwinderman
    • 2
  1. 1.Department MedicineAlbert Schweitzer HospitalSliedrechtThe Netherlands
  2. 2.Department of Biostatistics and EpidemiologyAcademic Medical CenterAmsterdamThe Netherlands

Bibliographic information

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