Development of standard clinical endpoints for use in dengue interventional trials

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dc.creatorTomashek, Kay M.
dc.creatorWills, Bridget
dc.creatorSee, Lucy Lum Chai
dc.creatorThomas, Laurent
dc.creatorDurbin, Anna P.
dc.creatorYee-Sin, Leo
dc.creatorBosch, Norma de
dc.creatorRojas Garrido, Elsa Marina
dc.creatorHendrickx, Kim
dc.creatorErpicum, Martin
dc.creatorSiqueira Júnior, João Bosco
dc.date.accessioned2025-01-22T13:03:56Z
dc.date.available2025-01-22T13:03:56Z
dc.date.issued2018
dc.description.abstractDengue is a major public health problem worldwide. Although several drug candidates have been evaluated in randomized controlled trials, none has been effective and at present, early recognition of severe dengue and timely supportive care are used to reduce mortality. While the first dengue vaccine was recently licensed, and several other candidates are in late stage clinical trials, future decisions regarding widespread deployment of vaccines and/ or therapeutics will require evidence of product safety, efficacy and effectiveness. Standard, quantifiable clinical endpoints are needed to ensure reproducibility and comparability of research findings. To address this need, we established a working group of dengue researchers and public health specialists to develop standardized endpoints and work towards consensus opinion on those endpoints. After discussion at two working group meet ings and presentations at international conferences, a Delphi methodology-based query was used to finalize and operationalize the clinical endpoints. Participants were asked to select the best endpoints from proposed definitions or offer revised/new definitions, and to indicate whether contributing items should be designated as optional or required. After the third round of inquiry, 70% or greater agreement was reached on moderate and severe plasma leakage, moderate and severe bleeding, acute hepatitis and acute liver failure, and moderate and severe neurologic disease. There was less agreement regarding moderate and severe thrombocytopenia and moderate and severe myocarditis. Notably, 68% of par ticipants agreed that a 50,000 to 20,000 mm3 platelet range be used to define moderate thrombocytopenia; however, they remained divided on whether a rapid decreasing trend or one platelet count should be case defining. While at least 70% agreement was reached on most endpoints, the process identified areas for further evaluation and standardization within the context of ongoing clinical studies. These endpoints can be used to harmonize data collection and improve comparability between dengue clinical trials.
dc.identifier.citationTOMASHEK, Kay M. et al. Development of standard clinical endpoints for use in dengue interventional trials. Plos Neglected Tropical Diseases, San Francisco, v. 12, e0006497, 2018. DOI: 10.1371/journal.pntd.0006497. Disponível em: https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0006497. Aceso em: 20 jan. 2025.
dc.identifier.doi10.1371/journal.pntd.0006497
dc.identifier.issne- 1935-2735
dc.identifier.issn1935-2727
dc.identifier.urihttp://repositorio.bc.ufg.br//handle/ri/26434
dc.language.isoeng
dc.publisher.countryEstados unidos
dc.publisher.departmentInstituto de Patologia Tropical e Saúde Pública - IPTSP (RMG)
dc.rightsAcesso Aberto
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.titleDevelopment of standard clinical endpoints for use in dengue interventional trials
dc.typeArtigo

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