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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.<\/jats:p>","DOI":"10.1093\/ofid\/ofag565","type":"journal-article","created":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T11:38:32Z","timestamp":1791027512000},"source":"Crossref","is-referenced-by-count":0,"title":["Rethinking Clinical Trial Design to Accelerate Therapeutics for Arboviral Epidemics"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8379-6857","authenticated-orcid":false,"given":"Andrea","family":"Alemany","sequence":"first","affiliation":[{"name":"Dengue Alliance (Geneva, Brazil, India, Malaysia and Thailand)"},{"name":"ISGlobal , Barcelona ,","place":["Spain"]},{"name":"Funda\u00e7\u00e3o de Medicina Tropical Dr Heitor Vieira Dourado (FMT-HVD) , Manaus ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6458-0900","authenticated-orcid":false,"given":"Maria 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