Ontology highlight
ABSTRACT: Background
As novel systemic therapeutics for patients with atopic dermatitis (AD) are developed, ethical and methodological concerns regarding placebo-controlled-trials (PCT) have surfaced.Objective
To guide the design and implementation of PCT in AD, focusing on trials with systemic medications.Methods
A subgroup of the International Eczema Council (IEC) developed a consensus e-survey, which was disseminated to IEC members.Results
The response rate was 43/82 (52%). Consensus was reached on 24/27 statements and on 3/11 options from multiple-selection statements, including: performing monotherapy studies in proof-of-concept phases; avoiding concomitant topical corticosteroids or calcineurin inhibitors until a predefined timepoint as rescue (borderline consensus); selection of sites and assessors with recognized expertise in AD clinical trials; clear definition and identification of baseline disease severity; minimizing time and proportion of patients on placebo; using daily emollients with several options provided; instigating open-label extension studies for enrolment after a predefined timepoint; and including outcomes which set a higher bar for disease clearance.Conclusion
Conducting PCT in AD requires balancing several, sometimes opposing principles, including ethics, methodology, regulatory requirements and real-world needs. This paper can provide a framework for conducting PCT with systemic medications for patients with AD.
SUBMITTER: Leshem YA
PROVIDER: S-EPMC6594032 | biostudies-literature | 2019 May
REPOSITORIES: biostudies-literature
Journal of the European Academy of Dermatology and Venereology : JEADV 20190312 5
<h4>Background</h4>As novel systemic therapeutics for patients with atopic dermatitis (AD) are developed, ethical and methodological concerns regarding placebo-controlled-trials (PCT) have surfaced.<h4>Objective</h4>To guide the design and implementation of PCT in AD, focusing on trials with systemic medications.<h4>Methods</h4>A subgroup of the International Eczema Council (IEC) developed a consensus e-survey, which was disseminated to IEC members.<h4>Results</h4>The response rate was 43/82 (52 ...[more]