Rethinking Clinical Trial Design to Accelerate Therapeutics for Arboviral Epidemics.

Authors

Andrea Alemany, Maria Paula Mourão, Ami Fazlin Bt Syed Mohamed, Steven Lim Chee Loon, Zaril Harza Bin Zakaria, Adriane Alves de Oliveira, Rozainanee Mohd Zain, Sergio Sosa-Estani, Manoel Barral-Netto, Meiruze Sousa Freitas, Marcus Vinicius Guimarães de Lacerda, Quique Bassat, Ganesan Karthikeyan, Prasert Auewarakul, Nor Fariza Ngah, Isabela Ribeiro, Andre M Siqueira, Mauro M Teixeira, Viviane Sampaio Boaventura, Dengue Alliance Clinical Experts Meeting Group, Dengue Alliance Clinical Experts Meeting Group

Published in

Open forum infectious diseases. Volume 13. Issue 10. Pages ofag565. Epub Oct 08, 2026.

Abstract

Arboviral diseases represent an escalating global health threat, yet therapeutic development has been markedly slower than for other viral illnesses. Key barriers include the unpredictability and variability of arbovirus transmission, which complicate site selection, limit recruitment, and increase delays and the risk of inconclusive trials. Additional challenges include maintaining trial-ready sites, recruitment within the narrow therapeutic window, ensuring rapid diagnostics, and including high-risk groups. To address these barriers, we propose several innovative strategies based on a Clinical Experts meeting convened by the Dengue Alliance. These include pre-activated trial networks for rapid initiation during outbreaks; early-warning surveillance to guide geographic activation using real-time transmission signals; decentralized trial models to expand recruitment beyond major research centers; platform trial designs that allow treatment arms to be added or discontinued adaptively; and participant inclusion based on clinical syndrome supported by rapid diagnostics. Their successful adoption requires regulatory harmonization, ethical oversight, and emphasis on equity.

PMID:
42851854
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

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