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Clinical Trials
A Methodologic Perspective
Second Edition
by Steven Piantadosi

Clinical Trials, Second Edition provides a straightforward and authoritative presentation of statistical methods for clinical trials.

Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of:

  • planning the experiment
  • assembling a study cohort
  • assessing data
  • reporting results

Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions.

Coverage of the Second Edition ranges from statistical principles to controversial topics, including alternative medicine and ethics. It offers pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct.

Contents

  1. Preliminaries
  2. Clinical Trails as Research
  3. Why Clinical Trials Are Ethical
  4. Contexts for Clinical Trials
  5. Statistical Perspectives
  6. Clinical Trials as Experimental Designs
  7. Random Error and Bias
  8. Objectives and Outcomes
  9. Translational Clinical Trials
  10. Dose Finding Designs
  11. Sample Size and Power
  12. The Study Cohort
  13. Treatment Allocation
  14. Treatment Effects Monitoring
  15. Counting Patients and Events
  16. Estimating Clinical Effects
  17. Prognostic Factor Analyses
  18. Reporting and Authorship
  19. Factorial Designs
  20. Cross-Over Designs
  21. Meta-Analyses
  22. Misconduct and Fraud in Clinical Research

Appendices

  • Data and Programs
  • Notation and Terminology
  • Abbreviations
  • Nuremberg Code
  • Declaration of Helsinki
  • NCI Data and Safety Monitoring Policy
  • NIH Data and Safety Monitoring Policy
  • Royal Statistical Society Code of Conduct

Index

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Clinical Trials
A Methodologic Perspective
Second Edition
by Steven Piantadosi

2005 687 pages $134.00 + shipping
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