Citation

Stewart M, Butler A, Alphs L, Chappell PB, Feltner DE, Lenderking WR, Mahableshwarkar AR, Makumi CW, Dubrava S. Innov. Clin. Neurosci. 2013; 10(5-6 Suppl A): 20S-28S.

Affiliation

Dr. Stewart is Sr. Director, Outcomes Research, Specialty Care Medicines Development Group, Pfizer, Inc., Groton, Connecticut; Dr. Butler is with Bracket, Wayne, Pennsylvania; Dr. Alphs is Therapeutic Area Leader Psychiatry, Janssen Scientific Affairs, Princeton, New Jersey; Dr. Chappell is with Pfizer Inc., Groton, Connecticut, and Yale School of Medicine, Child Study Center, New Haven, Connecticut; Dr. Feltner is Douglas E. Feltner LLC, Novi, Michigan; Dr. Lenderking is with United Biosource Inc., Lexington, Massachusetts; Dr. Mahableshwarkar is with Takeda Global Research and Development Center, Inc., Deerfield, Illinois; Dr. Makumi is with GlaxoSmithKline, Research Park Triangle, North Carolina; and Ms. DuBrava is with Pfizer Inc., Groton, Connecticut.

Copyright

(Copyright © 2013, Matrix Medical Communications)

DOI

unavailable

PMID

23882431

Abstract

OBJECTIVE: The International Society for CNS Clinical Trials and Methodology Suicidal Ideation and Behavior Assessment Working Group conducted an online survey regarding clinical trial site experiences and attitudes toward suicidal ideation and behavior data collection following the 2010 release of the initial United States Food and Drug Administration draft guidance on prospective assessment of suicidal ideation and behavior in clinical trials. Sites that had participated in at least one central nervous system clinical trial in the prior two years (N=6,058) were invited, via email, to complete a 20-item online assessment survey. RESULTS: Nine hundred and seventy-nine evaluable responses were collected (42% United States). Respondents included principal investigators (36%), raters (28%), coordinators (25%), and others (10%). The majority were psychiatrists (43%) and reported using suicidal ideation and behavior assessments across many indications. Most respondents (80%) personally conducted suicidal ideation and behavior assessments. Overall, respondents indicated that suicidal ideation and behavior assessments were readily incorporated into the conduct of clinical trials and improved subject safety. The greatest challenge was obtaining an accurate baseline lifetime history (51%), while the greatest benefit was identifying subjects at risk of suicide (84%). Approximately a quarter of respondents reported implementation challenges such as training. Differences based on geographical region, respondents' roles, and responsibility for assessments were observed. Open-ended responses revealed additional challenges, e.g., use in cognitively impaired populations. CONCLUSION: Prospective suicidal ideation and behavior monitoring was generally viewed positively, though specific challenges were identified. Limitations include self-report survey methodology and recruitment of only central nervous system clinical trials sites. These findings may help guide development of better methodologies for suicidal ideation and behavior assessment in clinical trials.

Language: en