Clinical Trial Design Challenges in Mood Disorders
Coordonnateurs : Tohen Mauricio, Bowden Charles, Nierenberg Andrew A., Geddes John
1. Clinical Trial Design of Maintenance Treatments in Bipolar Disorder
Mauricio Tohen
2. Meta-Analysis of Clinical Trials in Bipolar Disorder
John R. Geddes
3. Effectiveness Trials in Bipolar Disorders
Andrew A. Nierenberg
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
5. The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials
Edward Vieta and Núria Cruz
6. The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials
Michael Berk, Reneé Otmar, Olivia Dean, Lesley Berk and Erin Michalak
7. Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials
Charles L. Bowden and Vivek Singh
8. Novel Study Designs for Clinical Trials in Mood Disorders
Hong Jin Jeon and Maurizio Fava
9. Rating Scales in Bipolar Disorder
Martha Sajatovic, Peijun Chen and Robert C. Young
10. Clinical Applicability of Results from Drug Trials in Bipolar Disorder - An Attempt to Shed Light on a Complex Issue
Rasmus Wentzer Licht
11. Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation
Chittaranjan Andrade and Tim Appaiah
Researchers in clinical psychology and psychiatry. Practitioners treating mood disorders
Mauricio Tohen, MD, DrPH, MBA is the Chairman of the Department of Psychiatry at the University of New Mexico Health Sciences Center in Albuquerque NM, USA.
Dr Tohen was born and raised in Mexico City. He earned his medical degree from the National University of Mexico and his Doctorate in Public Health (Epidemiology) from Harvard University. His postdoctoral training included a residency in Psychiatry at the University of Toronto and a fellowship at McLean Hospital, Harvard Medical School. Dr Tohen also obtained an MBA degree from the Indiana University Kelly School of Business.
Dr Tohen was the Clinical Director of the Bipolar and Psychotic Disorders Program at McLean Hospital (1988-1997). In 1997 he joined Lilly Research Laboratories where he reached the senior most scientific rank of Distinguished Lilly Scholar. From 2009-2013 he was the Head of the Division of Mood & Anxiety Disorders and the Krus Endowed Tenured Professor in Psychiatry at the University of Texas Health Science Centre at San Antonio.
Among numerous awards, Dr Tohen received a National Service Award in Psychiatric Epidemiology from the National Institute of Mental Health (NIMH) and Harvard University. He also received a FIRST award from NIMH, the Pope Award from McLean Hospital, a NARSAD Young Investigator Award and in 2011 the Simon Bolivar Award from the American Psychiatric Association for outstanding contribution to education, research and overall achievement in Psychiatry and leadership in Hispanic Psychiatry. From 2010 to 2012, Dr Tohen was the President of the International Society for Bipolar Disorders. He is the President of the American Society of Hispanic Psychiatry (2014-2016).
Dr Tohen's research, supported by grants from NIMH, private foundations and the pharmaceutical industry, has focused on the epidemiology, outcome, and treatment of Bipolar and Psychotic Disorders. He has authored more than 250 original publications and edited or co-edited four books
- 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
Date de parution : 01-2015
Ouvrage de 192 p.
15x22.8 cm
Thème de Clinical Trial Design Challenges in Mood Disorders :
Mots-clés :
Adaptive designs; Bipolar; Bipolar CHOICE; Bipolar disorder; Clinical trial; Clinical trials; Continuation phase; Crossover; Design; Developing countries; Drug discovery; Effectiveness; Efficacy; Enriched design; Ethics; External validity; Generalizability; India; Informed consent; Internal validity; LiTMUS; Lithium; Maintenance phase; Maintenance treatment; Measurement; Meta-analysis; Methodologies; Methodology; Methods; Nonenriched design; Noninferiority; Outcomes; Pharmacology; Placebo; Placebo response; Psychiatry; Psychopharmacology; Qualitative; Randomization; Randomized; Randomized clinical trials; Rating scales; Recurrence; Regulatory environment; Relapse; Research synthesis; STEP-BD; Sequential parallel comparison design; Single blind; Switch; Systematic reviews; Treatment