Development of standard clinical endpoints for use in dengue interventional trials

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dc.contributorDivisão de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.authorTomashek, Kay Mariept_BR
dc.contributor.authorWills, Bridget A.pt_BR
dc.contributor.authorSee Lum, Lucy Chaipt_BR
dc.contributor.authorThomas, Laurentpt_BR
dc.contributor.authorDurbin, Anna P.pt_BR
dc.contributor.authorLeo, Yee Sinpt_BR
dc.contributor.authorDe Bosch, Norma Blumenfeldpt_BR
dc.contributor.authorRojas, Elsapt_BR
dc.contributor.authorHendrickx, Kimpt_BR
dc.contributor.authorErpicum, Martinpt_BR
dc.contributor.authorAgulto, Lianept_BR
dc.contributor.authorJäenisch, Thomaspt_BR
dc.contributor.authorTissera, Hasitha Aravindapt_BR
dc.contributor.authorSuntarattiwong, Piyaratpt_BR
dc.contributor.authorCollers, Beth Annpt_BR
dc.contributor.authorWallace, Derekpt_BR
dc.contributor.authorSchmidt, Alexander C.pt_BR
dc.contributor.authorPrecioso, Alexander Robertopt_BR
dc.contributor.authorNarvaez, Federicopt_BR
dc.contributor.authorThomas, Stephen J.pt_BR
dc.contributor.authorEdelman, Robertpt_BR
dc.contributor.authorSiqueira, João Boscopt_BR
dc.contributor.authorCassetti, Maria Cristinapt_BR
dc.contributor.authorDempsey, Wallapt_BR
dc.contributor.authorGubler, Duane J.pt_BR
dc.identifier.citationTomashek KM, Wills BA., See Lum LC, Thomas L, Durbin AP., Leo YS, et al. Development of standard clinical endpoints for use in dengue interventional trials. Plos Neglect. Trop. Dis.. 2018;12(10):e0006497. doi:10.1371/journal.pntd.0006497.pt_BR
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 meetings 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 participants 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.pt_BR
dc.publisherPublic Library Sciencept_BR
dc.relation.ispartofPlos Neglected Tropical Diseasespt_BR
dc.rightsOpen Accesspt_BR
dc.titleDevelopment of standard clinical endpoints for use in dengue interventional trialspt_BR
dc.contributor.externalNational Institutes of Health (NIH)¦¦Estados Unidospt_BR
dc.contributor.externalOxford University Clinical Research Unit Vietnam (OUCRU)¦¦Vietnãpt_BR
dc.contributor.externalUniversity of Malaya (UM)¦¦Malásiapt_BR
dc.contributor.externalJohns Hopkins Bloomberg School of Public Health¦¦Estados Unidospt_BR
dc.contributor.externalTan Tock Seng Hospital (TTSH)¦¦Singapurapt_BR
dc.contributor.externalUniversidad Central de Venezuela¦¦Venezuelapt_BR
dc.contributor.externalUniversidad Industrial de Santander¦¦Colômbiapt_BR
dc.contributor.externalUniversity of Liège (ULiège)¦¦Bélgicapt_BR
dc.contributor.externalSpiral Research Center¦¦Bélgicapt_BR
dc.contributor.externalUniversity Hospital Heidelberg¦¦Alemanhapt_BR
dc.contributor.externalNational Dengue Control Unit¦¦Sri Lankapt_BR
dc.contributor.externalQueen Sirikit National Institute of Child Health¦¦Tailândiapt_BR
dc.contributor.externalMerck Sharp and Dohme (MSD)¦¦Estados Unidospt_BR
dc.contributor.externalTakeda Pharmaceutical Company¦¦Suiçapt_BR
dc.contributor.externalUniversidade de São Paulo (USP)¦¦Brasilpt_BR
dc.contributor.externalHospital Infantil Manuel de Jesús Rivera¦¦Nicaráguapt_BR
dc.contributor.externalState University of New York (SUNY)¦¦Estados Unidospt_BR
dc.contributor.externalUniversity of Maryland School of Medicine¦¦Estados Unidospt_BR
dc.contributor.externalUniversidade Federal de Goiás (UFG)¦¦Brasilpt_BR
dc.contributor.externalDuke-NUS Medical School (Duke-NUS)¦¦Cingapurapt_BR
dc.publisher.citySan Franciscopt_BR
dc.relation.ispartofabbreviatedPlos Neglect. Trop. Dis.pt_BR
dc.identifier.citationabntv. 12, n. 10, e0006497, 2018pt_BR
dc.publisher.countryUnited Statespt_BR
dc.contributor.butantanPrecioso, Alexander Roberto|:Pesquisador|:Divisão de Ensaios Clínicos e Farmacovigilância|:pt_BR
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