Clinical Trial Design of Maintenance Treatments in Bipolar Disorder

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 Content: Front-matter, Pages i,iii Copyright, Page iv List of Contributors, Pages ix-x, Chittaranjan Andrade, Tim Appaiah, Lesley Berk, Michael Berk, Charles L. Bowden, Peijun Chen, Núria Cruz, Olivia Dean, Maurizio Fava, John R. Geddes, Heinz Grunze, Hong Jin Jeon, Rasmus Wentzer Licht, Erin Michalak, Andrew A. Nierenberg, Willem A. Nolen, Renée Otmar, Martha Sajatovic, Vivek Singh, Mauricio Tohen, Eduard Vieta, et al. Preface, Page xi, Mauricio Tohen, Charles L. Bowden, Andrew A. Nierenberg, John R. Geddes Chapter One - Clinical Trial Design of Maintenance Treatments in Bipolar Disorder, Pages 1-12, Mauricio Tohen Chapter Two - Meta-Analysis of Clinical Trials in Bipolar Disorder, Pages 13-22, John R. Geddes Chapter Three - Effectiveness Trials in Bipolar Disorders, Pages 23-28, Andrew A. Nierenberg Chapter Four - 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, Pages 29-47, Willem A. Nolen, Heinz Grunze Chapter Five - The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials, Pages 49-57, Eduard Vieta, Núria Cruz Chapter Six - The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials, Pages 59-74, Michael Berk, Renée Otmar, Olivia Dean, Lesley Berk, Erin Michalak Chapter Seven - Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials, Pages 75-86, Charles L. Bowden, Vivek Singh Chapter Eight - Novel Study Designs for Clinical Trials in Mood Disorders, Pages 87-104, Hong Jin Jeon, Maurizio Fava Chapter Nine - Rating Scales in Bipolar Disorder, Pages 105-136, Martha Sajatovic, Peijun Chen, Robert C. Young Chapter Ten - Clinical Applicability of Results from Drug Trials in Bipolar Disorder – An Attempt to Shed Light on a Complex Issue, Pages 137-165, Rasmus Wentzer Licht Chapter Eleven - Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation, Pages 167-173, Chittaranjan Andrade, Tim Appaiah Index, Pages 175-179

Poor clinical trial designs result in failed studies wasting hundreds of thousands of dollars in research funds. Poor clinical trial designs limit the rapid advancement of cures for disorders. Yet it’s relatively easy to avoid classic poor designs via education about what constitutes good design and what the potential outcomes are for any shortcuts taken. The proposed book outlines the classic problems that researchers are faced with in designing clinical trials, whether its money, selection of subjects, regulatory issues etc, and how best to address them for the most definitive and generalizable results. This book is specific to clinical trial issues in psychiatric research, and comes from a task force in Bipolar Research. The contents herein were identified as the most major issues in psychiatric research. Authored by international contributors from academia, industry, regulatory agencies, and advocacy groups, this book summarizes problems in clinical design and the results of same, and whether and how the results can be applied into clinical practice.

• Edited by highly respected experts in psychiatric clinical trials
• Encompasses issues in the academic, industry, and regulatory worlds
• Includes clinical design and analysis
• Encompasses translation of research findings into practice

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. Poor clinical trial designs result in failed studies wasting hundreds of thousands of dollars in research funds. Poor clinical trial designs also limit the rapid advancement of cures for disorders, yet it's relatively easy to avoid classic errors via education about what constitutes good design and what the potential outcomes are for any shortcuts taken. This book outlines the classic problems that researchers are faced with in designing clinical trials, whether its money, selection of subjects, regulatory issues etc, and how best to address them for the most definitive and generalizable results