Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy.
Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy.
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DOI：
10.1016/j.vaccine.2016.07.007
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发表时间：
2016-12-01
期刊：
影响因子：
5.5
通讯作者：
Heath PT
中科院分区：
文献类型：
--
作者：
Jones CE;Munoz FM;Kochhar S;Vergnano S;Cutland CL;Steinhoff M;Black S;Heininger U;Bonhoeffer J;Heath PT
孕期接种疫苗是预防母亲及其婴儿严重感染的有效策略。这一战略的安全性对所有利益攸关方至关重要。随着评估孕期疫苗安全性的研究数量增加，确保一致收集和报告关键数据以进行比较和数据汇集的必要性变得更加重要。全球统一孕期免疫安全评估(GAIA)项目旨在改进数据收集，建立对产妇、胎儿和新生儿结局的共同理解，以推动孕期接种疫苗的全球议程。本文件中的指导意见是为了协调在孕妇接种疫苗临床试验中用于安全监测的病例报告表中收集的数据。将收集的数据按优先顺序排列，以便在不同的研究环境中适用，包括低收入和中等收入国家。标准化数据将使研究界有一个共同的基础，在此基础上进行荟萃分析，加强成果对不同环境的适用性。
Vaccination in pregnancy is an effective strategy to prevent serious infections in mothers and their infants. Safety of this strategy is of principal importance to all stakeholders. As the number of studies assessing safety of vaccines in pregnancy increases, the need to ensure consistent collection and reporting of critical data to allow comparisons and data pooling becomes more important. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project aims to improve data collection and create a shared understanding of maternal, fetal and neonatal outcomes in order to progress the global agenda for vaccination in pregnancy. The guidance in this document has been developed to harmonize the data collected in case report forms used for safety monitoring in clinical trials of vaccination in pregnant women. Data to be collected is prioritized to allow applicability in diverse research settings, including low and middle-income countries. Standardized data will enable the research community to have a common base upon which to conduct meta-analyses, strengthening the applicability of outcomes to different settings.
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