Statistics Applied to Clinical Trials

  • Ton J. Cleophas
  • Aeilko H. Zwinderman
  • Toine F. Cleophas

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 1-16
  3. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 17-38
  4. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 39-46
  5. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 47-52
  6. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 53-64
  7. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 65-71
  8. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 73-82
  9. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 83-94
  10. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 95-104
  11. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 105-117
  12. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 119-132
  13. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 133-142
  14. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 143-150
  15. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 151-155
  16. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 157-166
  17. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 167-176
  18. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 177-189
  19. Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
    Pages 191-197
  20. Back Matter
    Pages 199-210

About this book

Introduction

In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to low sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were recognized and subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses, etc. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly better quality than before. The past decade has focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial bodies, including ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses.
This book not only explains classical statistical analyses of clinical trials, but addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. The book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.

Keywords

Logistic Regression Regression analysis correlation linear regression statistical inference statistics

Authors and affiliations

  • Ton J. Cleophas
    • 1
    • 2
  • Aeilko H. Zwinderman
    • 1
    • 3
  • Toine F. Cleophas
    • 4
  1. 1.European Interuniversity College of Pharmaceutical Medicine LyonFrance
  2. 2.Department MedicineAlbert Schweitzer HospitalDordrechtThe Netherlands
  3. 3.Department Biostatistics and EpidemiologyAcademic Medical Center AmsterdamThe Netherlands
  4. 4.Technical UniversityDelftThe Netherlands

Bibliographic information

  • DOI https://doi.org/10.1007/978-94-010-0337-7
  • Copyright Information Kluwer Academic Publishers 2002
  • Publisher Name Springer, Dordrecht
  • eBook Packages Springer Book Archive
  • Print ISBN 978-1-4020-0570-1
  • Online ISBN 978-94-010-0337-7
  • About this book