Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

Issue link: http://innovationscns.epubxp.com/i/425963

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R - O C T O B E R 2 0 1 4 ] 14 ABSTRACT Objective: To survey the current approaches of clinical trial sponsors in prospective suicidal ideation and behavior assessments and challenges encountered. Design: An internet-based survey. Setting: Inclusion of prospective assessments of suicidal ideation and behavior in industry-sponsored clinical studies were required following the release of the September 2010 United States Federal Drug Administration draft guidance. The International Society for CNS Clinical Trials and Methodology Suicidal Ideation and Behavior Assessment Workgroup conducted an online survey to understand industry practices and experiences in implementing suicidal ideation and behavior assessments in clinical trials. Participants: The survey was sent to 1,447 industry employees at 178 pharmaceutical companies. A total of 89 evaluable responses, representing 39 companies, were obtained. Measurements: A 30-item internet survey was developed asking about potential challenges and issues in implementing prospective suicidal ideation and behavior assessments. Results: Common factors in deciding whether to include suicidal ideation and behavior assessments in a clinical trial were psychiatric or neurologic drug product (95%); central nervous system activity (78%); disease (74%) and patient population (71%); and regulatory announcements and policies (74%). by ISCTM SUICIDAL IDEATION AND BEHAVIOR ASSESSMENT WORKGROUP: PHILLIP B. CHAPPELL, MD; ATUL R. MAHABLESHWARKAR, MD; LARRY D. ALPHS, MD, PhD; MARK E. BANGS, MD; ADAM BUTLER, BA; SARAH J. DuBRAVA, MS; JOHN H. GREIST, MD; WILLIAM R. LENDERKING, PhD; JAMES C. MUNDT, PhD; and MICHELLE STEWART, PhD Dr. Chappell is with Pfizer, Inc., Groton, Connecticut; Dr. Mahableshwarkar is with Takeda Pharmaceutical Company, Deerfield, Illinois; Dr. Alphs is with Janssen Scientific Affairs, Titusville, New Jersey; Dr. Bangs is with Eli Lilly and Company, Indianapolis, Indiana; Mr. Butler is with Bracket Global, Wayne, Pennsylvania; Ms. DuBrava is with Pfizer, Inc., Groton, Connecticut; Dr. Greist is Clinical Adjunct Professor of Psychiatry at University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin; Dr. Lenderking is with Evidera, Bethesda, Maryland; Dr. Mundt is with Center for Telepsychology, Madison, Wisconsin; and Dr. Stewart is with Pfizer, Groton, Connecticut. Innov Clin Neurosci. 2014;11(9–10):14–22 FUNDING: There was no funding for the development and writing of this article. FINANCIAL DISCLOSURES: Dr. Chappell is a full-time employee of Pfizer, Inc., Groton, Connecticut; Dr. Mahableshwarker is a full-time employee of Takeda Pharmaceutical Company, Deerfield, Illinois; Dr. Alphs is employed by Janssen Scientific Affairs, Titusville, New Jersey, and is a stockholder of Johnson & Johnson; Dr. Bangs has no conflicts of interest relevant to the content of this article; Mr. Butler is an employee of Bracket Global, Wayne, Pennsylvania; Ms. DuBrava is an employee of Pfizer, Inc. and holds stock in the company; Dr. Greist is a co-developer and coauthor of the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) and a principal at Healthcare Technology Systems, Inc., which receives royalties from eC-SSRS use; Dr. Lenderking is a stockholder of Pfizer, Inc., Groton, Connecticut; Dr. Mundt is a stockholder in Healthcare Technology Systems, which receives royalties from ERT for the development and validation of the eC- SSRS. ERT supported the meta-analysis of the reported data and preparation of the manuscript for publication submission; Dr. Stewart is a full-time employee of Pfizer, Inc., Groton, Connecticut. ADDRESS CORRESPONDENCE TO: Phillip Chappell, MD, MBA, Pfizer, Inc., 455 Eastern Point Rd., Groton CT 06340; Phone: (860) 271-9947; Fax: (860) 715-7527: Email: Phillip.b.chappell@pfizer.com KEY WORDS: Prospective assessment of suicidal ideation and behavior in industry studies, C-SSRS in industry studies [ O R I G I N A L R E S E A R C H ] Prospective Assessment of Suicidal Ideation and Behavior: An Internet Survey of Pharmaceutical Sponsor Practices

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