Prevention and Treatment of Missing Data in Clinical Trials
eBook - PDF

Prevention and Treatment of Missing Data in Clinical Trials

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  1. 163 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Prevention and Treatment of Missing Data in Clinical Trials

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About this book

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups.Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable.The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

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Edition
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Table of contents

  1. FrontMatter
  2. Acknowledgments
  3. Contents
  4. Glossary
  5. Summary
  6. 1 Introduction and Background
  7. 2 Trial Designs to Reduce the Frequency of Missing Data
  8. 3 Trial Strategies to Reduce the Frequency of Missing Data
  9. 4 Drawing Inferences from Incomplete Data
  10. 5 Principles and Methods of Sensitivity Analyses
  11. 6 Conclusions and Recommendations
  12. References
  13. Appendix A: Clinical Trials: Overview and Terminology
  14. Appendix B: Biographical Sketches of Panel Members and Staff
  15. Committee on National Statistics