Atopic dermatitis: elements in clinical study design and analysis.
Considerations in design and analysis of clinical trials in atopic dermatitis are discussed. Since studies analyzed statistically provide an impression of the "probable" effect on the "average" patient, the value of the conclusions depends on the limits imposed by the investigator(s) on factors such as sample size, heterogeneity of the patient population, relevance of the parameters measured and biases introduced in data collection and management. Suggestions are provided for inclusion/exclusion criteria, variables to be measured, sign/symptom scoring systems and data presentations in studies involving patients with atopic dermatitis.
Abrams
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Dermatology Medical Research, Hoechst-Roussel Pharmaceuticals, Inc., Somerville, NJ 08876.
D015982:Bias; D002986:Clinical Trials as Topic; D003625:Data Collection; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D006801:Humans; D011897:Random Allocation; D012107:Research Design