A Noninferiority Margin for Acne Lesion Counts

When comparing different active treatments, a noninferiority—also called one-sided equivalence—study design is used. This study design requires the definition of a noninferiority margin, the threshold value of clinical relevance. At present, a noninferiority margin of 10 percentage points is convent...

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Bibliographic Details
Published in:Drug information journal 2008-11, Vol.42 (6), p.607-615
Main Authors: Gerlinger, Christoph, Städtler, Gerald, Götzelmann, Ralf, Graupe, Klaus, Endrika, Jan
Format: Article
Language:English
Subjects:
Acne
Birth control
Clinical trials
Discriminant analysis
Drug Safety and Pharmacovigilance
Empirical analysis
Lesions
Medical treatment
Patients
Pharmacotherapy
Pharmacy
Placebo effect
Sample size
Self-assessment
Sensitivity analysis
Standard deviation
Statistical methods
Statistics
Subjective assessment
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Summary:When comparing different active treatments, a noninferiority—also called one-sided equivalence—study design is used. This study design requires the definition of a noninferiority margin, the threshold value of clinical relevance. At present, a noninferiority margin of 10 percentage points is conventionally used for the change in acne lesion counts, but it lacks empirical validation. We analyzed the data of 4,081 patients with moderate to severe facial acne. The treatment effect was recorded by the investigator as the relative change in lesion counts from baseline (objective assessment). At the end of the treatment period, patients rated themselves as having their acne condition improved, unchanged, or worsened (subjective assessment). We compared the changes in lesion counts with the patients' self-assessment to derive an empirically validated noninferiority margin. We found that an empirically validated noninferiority margin of 10–15 percentage points for facial acne lesion counts is appropriate.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286150804200608