Randomized clinical trials: design, practice and reporting

Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting.

Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organizations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level.

Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.

Introduction.

Historical development.

Randomisation.

Design of trials.

Sample size.

Practical issues.

Clinical trials offices.

Data monitoring.

Basic analysis.

Design and analysis of other designs.

Reporting.

Meta analysis of other designs.

Conclusions.