title: The need for expanded monitoring of adverse events in behavioral health clinical trials.
abstract: 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.
authors.affiliation: Department of Psychiatry, University of Texas Health Science Center at San Antonio, TX 78229-3900,USA. petersona3@uthscsa.edu
authors.forename: Alan L
authors.initials: AL
authors.lastname: Peterson
authors.forename: John D
authors.initials: JD
authors.lastname: Roache
authors.forename: Jeslina
authors.initials: J
authors.lastname: Raj
authors.forename: Stacey
authors.initials: S
authors.lastname: Young-McCaughan
mesh_terms: D032763:Behavior Control / Q000379:methods*; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D013811:Psychotherapeutic Processes; D011618:Psychotic Disorders / Q000523:psychology / Q000628:therapy*