Optimization of placebo use in clinical trials with systemic treatments for atopic dermatitis: an International Eczema Council survey-based position statement.

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 consen

SUBMITTER: Leshem YA 

PROVIDER: S-EPMC6594032 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature