Citation

Sheehan DV, Giddens JM, Sheehan KH. Innov. Clin. Neurosci. 2014; 11(9-10): 54-65.

Affiliation

Dr. D. Sheehan is Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida; J. Giddens is the Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. K. Sheehan is Associate Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida.

Copyright

(Copyright © 2014, Matrix Medical Communications)

DOI

unavailable

PMID

25520889

Abstract

OBJECTIVE: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria.

METHOD: A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored.

RESULTS: The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time.

CONCLUSION: These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality.

Language: en