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ClinicalTrials.Gov: Pitfalls for pregnant women looking to enroll in studies

The common exclusion of pregnant women from clinical HIV research warrants inquiry into those few studies that do include pregnant women. This commentary highlights some of the pitfalls of the ClinicalTrials.gov platform for its intended users--study participants, particularly pregnant women--and in...

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Detalles Bibliográficos
Autores principales: Franceschini, Robert, Wicks, Sarah L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8810363/
https://www.ncbi.nlm.nih.gov/pubmed/35128141
http://dx.doi.org/10.1016/j.conctc.2022.100890
Descripción
Sumario:The common exclusion of pregnant women from clinical HIV research warrants inquiry into those few studies that do include pregnant women. This commentary highlights some of the pitfalls of the ClinicalTrials.gov platform for its intended users--study participants, particularly pregnant women--and investigators looking to use its data for study. Some of the pitfalls include missing information; lack of historical reporting enforcement; difficulty searching for studies focused on pregnant women versus the fetus; inability to consistently find studies targeted at specific stages of pregnancy; and lack of information relating to whether a study intervention is investigational or previously approved by the FDA.