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Prospective assessment of suicidal ideation and behavior: an internet survey of pharmaceutical sponsor practices

, Phillip B Chappell1, Atul R Mahableshwarkar1

  • 1Dr. 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.

Innovations in Clinical Neuroscience
|December 19, 2014
PubMed
Abstract

Insights

Clinical trial sponsors widely implement suicidal ideation and behavior assessments, often using the Columbia-Suicide Severity Rating Scale. Challenges include cross-cultural differences and rater training, impacting data consistency.

Area of Science:

  • Clinical trial methodology
  • Psychiatric research
  • Regulatory science

Background:

  • The US FDA issued guidance in 2010 for prospective suicidal ideation and behavior assessments in clinical trials.
  • The International Society for CNS Clinical Trials and Methodology Suicidal Ideation and Behavior Assessment Workgroup aimed to understand industry practices.

Purpose of the Study:

  • To survey clinical trial sponsors' current approaches to prospective suicidal ideation and behavior assessments.
  • To identify challenges encountered during the implementation of these assessments.

Main Methods:

  • An online survey was distributed to 1,447 industry employees across 178 pharmaceutical companies.
  • A 30-item survey assessed challenges and issues in implementing prospective suicidal ideation and behavior assessments.
  • 89 evaluable responses from 39 companies were analyzed.

Main Results:

  • High implementation rates (95%) for assessments in psychiatric/neurologic drug trials, driven by CNS activity, disease, patient population, and regulations.
  • Key challenges included cross-cultural differences (40%), baseline history (36.8%), translations (35%), rater discomfort (32%), and inadequate rater training (30%).

Conclusions:

  • Implementation of suicidal ideation and behavior assessments in CNS studies is high, with the Columbia-Suicide Severity Rating Scale being commonly used.
  • Challenges in standardization and data analysis raise concerns about inconsistent reporting and cross-study data integration.
Keywords:
C-SSRS in industry studiesProspective assessment of suicidal ideation and behavior in industry studies

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