Development of standard clinical endpoints for use in dengue interventional trials
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2018
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Dengue 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.
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TOMASHEK, 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.