Steven Piantadosi 
Clinical Trials 
A Methodologic Perspective

Learn rigorous statistical methods to ensure valid clinicaltrials

This Second Edition of the critically hailed Clinical Trials buildson the text’s reputation as a straightforward and authoritativepresentation of statistical methods for clinical trials. Readersare introduced to the fundamentals of design for various types ofclinical trials and then skillfully guided through the completeprocess of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, theauthor alerts readers to problems that may arise during the courseof the trial and provides commonsense solutions.

The author bases the revisions and updates on his own classroomexperience, as well as feedback from students, instructors, andmedical and statistical professionals involved in clinical trials.The Second Edition greatly expands its coverage, ranging fromstatistical principles to controversial topics, includingalternative medicine and ethics. At the same time, it offers morepragmatic advice for issues such as selecting outcomes, samplesize, analysis, reporting, and handling allegations of misconduct.Readers familiar with the First Edition will discover completelynew chapters, including:
* Contexts for clinical trials
* Statistical perspectives
* Translational clinical trials
* Dose-finding and dose-ranging designs

Each chapter is accompanied by a summary to reinforce the keypoints. Revised discussion questions stimulate critical thinkingand help readers understand how they can apply their newfoundknowledge, and updated references are provided to direct readers tothe most recent literature.

This text distinguishes itself with its accessible and broadcoverage of statistical design methods–the crucial building blocksof clinical trials and medical research. Readers learn to conductclinical trials that produce valid qualitative results backed byrigorous statistical methods.

Innehållsförteckning

Preface.

Preface to the First Edition.

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.

Appendix A: Data and Programs.

Appendix B: Notation and Terminology.

Appendix C: Abbreviations.

Appendix D: Nuremberg Code.

Appendix E: Declaration of Helsinki.

Appendix F: NCI Data and Safety Monitoring Policy.

Appendix G: NIH Data and Safety Monitoring Policy.

Appendix H: Royal Statistical Society Code of Conduct.

Bibliography.

Author Index.

Subject Index.

Om författaren

STEVEN PIANTADOSI, MD, Phd, is Professor of Oncology and Director of Biostatistics at the Johns Hopkins Oncology Center. He also holds appointments in the Departments of Biostatistics and Epidemiology at the Bloomberg School of Public Health at John Hopkins University. Dr. Piantadosi has taught clinical trials for seventeen years and is the author or coauthor of more than 250 scholarly articles.