|
Citation
|
Chappell PB, Mahableshwarkar AR, Alphs LD, Bangs ME, Butler A, DuBrava SJ, Greist JH, Lenderking WR, Mundt JC, Stewart M. Innov. Clin. Neurosci. 2014; 11(9-10): 14-22. |
|
Affiliation
|
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. |
|
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clinical studies were required following the release of the September 2010 United States Federal Drug Administration draft guidance.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%). The most common challenges in implementing suicidal ideation and behavior assessments included cross-cultural differences in acceptance of SIB assessments (40%); obtaining adequate baseline history (36.8%); obtaining translations (35%); investigator/rater discomfort with asking about suicidal ideation and behavior (32%); and inadequate training of raters to administer suicidal ideation and behavior ratings (30%).
CONCLUSION: Among sponsors surveyed, the implementation rate of suicidal ideation and behavior assessment in central nervous systems studies is very high. Most have used the Columbia-Suicide Severity Rating Scale. Challenges regarding standardization of retrospective assessment timeframes and differing approaches to summarizing and analyzing suicidal ideation and behavior-related study data were frequently reported. These results suggest that inconsistent reports of suicidal ideation and behavior within study datasets may occur and that integration of data across studies remains a concern.
Language: en |