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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 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

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

Leshem Y A YA   Bissonnette R R   Paul C C   Silverberg J I JI   Irvine A D AD   Paller A S AS   Cork M J MJ   Guttman-Yassky E E  

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]

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