Clinical trial design challenges in mood disorders / edited by Mauricio Tohen [and three others].

Format:

Book

Contributor:

Tohen, Mauricio, editor.

Language:

English

Subjects (All):

Affective disorders.

Bipolar Disorder--therapy.

Mood Disorders--therapy.

Clinical Trials as Topic.

Medical Subjects:

Bipolar Disorder--therapy.

Mood Disorders--therapy.

Clinical Trials as Topic.

Physical Description:

1 online resource (192 p.)

Edition:

1st ed.

Place of Publication:

London, England : Academic Press, 2015.

Language Note:

English

Summary:

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

Contents:

Clinical trial design and maintenance treatments in bipolar disorder

Meta-analysis of clinical trials in bipolar disorder

Effectiveness trials in bipolar disorders

Long-term treatment of mood disorders : follow-up of acute treatment phases studies versus continuation and maintenance phase studies, and enriched versus non-enriched designs

The role of noninferiority designs in bipolar disorder clinical trials

The use of mixed methods in drug discovery : integrating qualitative methods into clinical trials

Sequential multiple assignment randomized treatment (SMART) : designs in bipolar disorder clinical trials

Novel study designs for clinical trials in mood disorders

Rating scales in bipolar disorder

Clinical applicability of results from drug trials in bipolar disorder

an attempt to shed light on a complex issue

Clinical trials in developing countries : challenges in design, execution, and regulation.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references at the end of each chapters and index.

Description based on print version record.

ISBN:

0-12-405176-6

OCLC:

900781265