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.