Clinical Trial Design Challenges in Mood Disorders

by Mauricio Tohen (Editor), Charles Bowden (Editor), Andrew A. Nierenberg (Editor), John Geddes (Editor)

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

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