For a study, it was determined that treatment of moderate-to-severe atopic dermatitis resulted in novel and developing therapeutic options for the chronic inflammatory skin condition. The fast evolution resulted in an inconsistency in research designs, trial conduct, and statistical analysis. The interpretation of how differences in study parameters may impact clinical trial findings was a difficulty for healthcare practitioners.
Researchers prepared a list of 22 essential study characteristics of modern clinical trials in moderate-to-severe atopic dermatitis and rated the top study factors that had a substantial influence on effectiveness outcomes based on a review of the literature and our experience as clinical trialists. The most important parameters were study comparators, rescue treatment rules, washout periods for topical and systemic treatments, inclusion criteria such as disease severity as measured by the Eczema Area and Severity Index and/or Investigator Global Assessment scores, and the duration of the screening period.
They discussed critical parameter concerns, with an emphasis on between-parameter interactions and their impact on effectiveness outcomes. This may help to guide the interpretation of atopic dermatitis clinical trials and increase awareness of the need for clinical trial design harmonization.