Full Description
Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients.
Contents
Preface
1. Clinical Trial Design of Maintenance Treatments in Bipolar Disorder
Mauricio Tohen
2. Meta-Analysis of Clinical Trials in Bipolar Disorder
John R. Geddes
3. Effectiveness Trials in Bipolar Disorders
Andrew A. Nierenberg
4. Long-Term Treatment of Mood Disorders: Follow-Up of Acute Treatment Phase Studies Versus Continuation and Maintenance Phase Studies, and Enriched Versus Non-Enriched Designs
Willem A. Nolen and Heinz Grunze
5. The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials
Edward Vieta and Núria Cruz
6. The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials
Michael Berk, Reneé Otmar, Olivia Dean, Lesley Berk and Erin Michalak
7. Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials
Charles L. Bowden and Vivek Singh
8. Novel Study Designs for Clinical Trials in Mood Disorders
Hong Jin Jeon and Maurizio Fava
9. Rating Scales in Bipolar Disorder
Martha Sajatovic, Peijun Chen and Robert C. Young
10. Clinical Applicability of Results from Drug Trials in Bipolar Disorder - An Attempt to Shed Light on a Complex Issue
Rasmus Wentzer Licht
11. Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation
Chittaranjan Andrade and Tim Appaiah
