Design issues and outcomes in IBD clinical trials

Bruce E. Sands, Maria T. Abreu, George D. Ferry, Anne M. Griffiths, Stephen B. Hanauer, Kim L. Isaacs, James D. Lewis, William J. Sandborn, A. Hillary Steinhart, Marjorie Merrick

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

Successful clinical trials in inflammatory bowel disease are based on precise definitions of study populations, standardized and well-defined interventions, reliable indices of disease activity, and clearly stipulated outcome measures. Interpretation of research results is often complicated by the differentiation of goals of therapy (remission induction and maintenance, quality of life) and the multitude of patient subsets. Choosing the correct patient subtype to enroll in a clinical trial is critical to the results of a study, its conclusions, and its applicability to the clinical setting. Validated, easy-to-use disease activity indices allow interpretation of results across trials. The use of biomarkers as surrogate clinical endpoints provides reproducibility, ease of statistical handling as a continuous variable, and consistent measurement of response to treatment. Despite these potential advantages, biomarkers of disease activity lack specificity and will need to be validated against clinically meaningful outcomes. Careful subject selection, standardization of disease activity indices, and precise outcome measurement are the keys to continued improvement of the inflammatory bowel disease research process.

Original languageEnglish (US)
Pages (from-to)S22-S28
JournalInflammatory bowel diseases
Volume11
Issue numberSUPPL. 1
DOIs
StatePublished - Nov 1 2005
Externally publishedYes

Keywords

  • Biomarker
  • Disease activity index
  • Inflammatory bowel disease
  • Patient subtype

ASJC Scopus subject areas

  • Gastroenterology

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    Sands, B. E., Abreu, M. T., Ferry, G. D., Griffiths, A. M., Hanauer, S. B., Isaacs, K. L., Lewis, J. D., Sandborn, W. J., Steinhart, A. H., & Merrick, M. (2005). Design issues and outcomes in IBD clinical trials. Inflammatory bowel diseases, 11(SUPPL. 1), S22-S28. https://doi.org/10.1097/01.MIB.0000184849.38816.39