| Description |
xxvii, 687 pages : illustrations ; 26 cm |
| Series |
Wiley series in probability and statistics |
|
Wiley series in probability and statistics.
|
| Contents |
1. Preliminaries -- 2. Clinical trials 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 subjects and events -- 16. Estimating clinical effects -- 17. Prognostic factor analyses -- 18. Reporting and authorship -- 19. Factorial designs -- 20. Crossover designs -- 21. Meta-analyses -- 22. Misconduct and fraud in clinical research -- A. Data and programs -- B. Notation and terminology -- C. Abbreviations -- D. Nuremberg Code -- E. Declaration of Helsinki -- F. NCI data and safety monitoring policy -- G. NIH data and safety monitoring policy -- H. Royal Statistical Society code of conduct |
| Summary |
"This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as 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, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions." "The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct."--BOOK JACKET |
| Bibliography |
Includes bibliographical references (pages 613-658) and indexes |
| Subject |
Clinical trials -- Statistical methods.
|
|
Biomedical Research -- methods.
|
|
Research Design.
|
|
Clinical Trials as Topic -- methods.
|
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Statistics as Topic -- methods.
|
| LC no. |
2005040833 |
| ISBN |
0471727814 (cloth : alk. paper) |
|
9780471727 (81) |
|
