Clinical Trial Design Challenges in Mood Disorders

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 trialsEncompasses issues in the academic, industry, and regulatory worldsIncludes clinical design and analysis Encompasses translation of research findings into practice INDICE: Chap 1: Challenges in conducting clinical trials in developing countries Chap 2: Regulatory issues In clinical trials Chap 3: Effectiveness trials Chap 4: New statistical approaches in clinical trials Chap 5: Generalizability issues Chap 6: Enriched vs. non-enriched designs in maintenance treatment Chap 7: Role of Non-inferiority designs in clinical trials Chap 8: Maintenance trials design Chap 9: SMART designs in clinical trials Chap 10: Q twist methodology application Chap 11: Challenges of psychosocial clinical trials Chap 12: Meta-analysis and The Cochran library in clinical trials Chap 13: Longitudinal Assessment Chap 14: Rating Scales Chap 15: Challenges of Clinical trial design across psychiatric conditions

• ISBN: 978-0-12-405170-6
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 192
• Fecha Publicación: 16/03/2015
• Nº Volúmenes: 1
• Idioma: Inglés