Clinical trial design challenges in mood disorders / [electronic resource]
by Tohen, Mauricio [editor.]; Bowden, Charles L [editor.]; Nierenberg, Andrew A. (Andrew Alan) [editor.]; Geddes, John R [editor.].
Material type:
BookPublisher: London, UK : Academic Press, [2015]Description: 1 online resource.ISBN: 9780124051768; 0124051766.Subject(s): Affective disorders | Manic-depressive illness | PSYCHOLOGY -- Psychopathology -- Bipolar Disorder | Affective disorders | Manic-depressive illness | Bipolar Disorder -- therapy | Mood Disorders -- therapy | Clinical Trials as Topic | Electronic book | Electronic books | Electronic booksOnline resources: ScienceDirect Vendor-supplied metadata.
Includes bibliographical references and index.
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.
Preface
Chapter 1: Clinical Trial Design of Maintenance Treatments in Bipolar Disorder Mauricio Tohen
Chapter 2: Meta-Analysis of Clinical Trials in Bipolar Disorder John R. Geddes
Chapter 3: Effectiveness Trials in Bipolar Disorders Andrew A. Nierenberg
Chapter 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
Chapter 5: The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials Edward Vieta and N�uria Cruz
Chapter 6: The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials Michael Berk, Rene�e Otmar, Olivia Dean, Lesley Berk and Erin Michalak
Chapter 7: Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials Charles L. Bowden and Vivek Singh
Chapter 8: Novel Study Designs for Clinical Trials in Mood Disorders Hong Jin Jeon and Maurizio Fava
Chapter 9: Rating Scales in Bipolar Disorder Martha Sajatovic, Peijun Chen and Robert C. Young
Chapter 10: Clinical Applicability of Results from Drug Trials in Bipolar Disorder -- An Attempt to Shed Light on a Complex Issue Rasmus Wentzer Licht
Chapter 11: Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation Chittaranjan Andrade and Tim Appaiah
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