Clinical Trial Design Challenges in Mood Disorders

著者名：Tohen, Mauricio (EDT)/Bowden, Charles (EDT)/Nierenberg, Andrew A. (EDT)/Geddes, John (EDT)

Academic Press（2015/01/24発売）

• 言語：ENG
• ISBN：9780124051706
• eISBN：9780124051768

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.- Summarizes common trial design problems and their solutions- Encompasses funding, subject selection, regulatory issues and more- Identifies best practices for definitive and generalizable results- Includes traditional trial designs and novel analytic techniques- Represents academia, industry, regulatory agencies, and advocacy groups

Table of Contents

Preface 1. Clinical Trial Design of Maintenance Treatments in Bipolar DisorderMauricio Tohen 2. Meta-Analysis of Clinical Trials in Bipolar DisorderJohn R. Geddes 3. Effectiveness Trials in Bipolar DisordersAndrew 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 DesignsWillem A. Nolen and Heinz Grunze 5. The Role of Noninferiority Designs in Bipolar Disorder Clinical TrialsEdward Vieta and Núria Cruz 6. The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical TrialsMichael Berk, Reneé Otmar, Olivia Dean, Lesley Berk and Erin Michalak 7. Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical TrialsCharles L. Bowden and Vivek Singh 8. Novel Study Designs for Clinical Trials in Mood DisordersHong Jin Jeon and Maurizio Fava 9. Rating Scales in Bipolar DisorderMartha 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 IssueRasmus Wentzer Licht 11. Clinical Trials in Developing Countries: Challenges in Design, Execution, and RegulationChittaranjan Andrade and Tim Appaiah