Clinical Trial Design Challenges in Mood Disorders
Tohen M., Bowden CL., Nierenberg AA., Geddes JR.
© 2015 Elsevier Inc. All rights reserved. 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.