Document Detail

The Need for Expanded Monitoring of Adverse Events in Behavioral Health Clinical Trials.
MedLine Citation:
PMID:  23117077     Owner:  NLM     Status:  Publisher    
Monitoring for possible adverse events is ethically required by Institutional Review Boards and Good Clinical Practice guidelines for all human research involving the delivery of treatment interventions in a clinical trial. The monitoring of adverse events is a well-established and routine practice for contemporary clinical trials involving medications and medical devices. However, these same guidelines have not been fully integrated into clinical trials involving the use of behavioral health interventions and psychotherapy. Most behavioral health clinical trials limit adverse event monitoring to serious adverse events such as suicide attempts, completed suicides, and psychiatric hospitalizations. Other possible "side effects" of psychotherapy, such as temporary increases in anxiety, are often considered a normal part of therapy and are therefore not documented as possible adverse events. This manuscript reviews a variety of reasons for the limited adverse event monitoring in behavioral health clinical trials and highlights the importance of incorporating expanded adverse event monitoring into future behavioral health clinical trials. Without understanding the nature and prevalence of adverse events, patients cannot be informed adequately of the possible risks and benefits of behavioral interventions prior to engaging in treatment.
Alan L Peterson; John D Roache; Jeslina Raj; Stacey Young-McCaughan;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-29
Journal Detail:
Title:  Contemporary clinical trials     Volume:  -     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-11-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
Department of Psychiatry, University of Texas Health Science Center at San Antonio. Electronic address:
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