3/27/2023 0 Comments R gaia project![]() ![]() The intention is also to optimize the use of data obtained from participants in clinical trials by improving data accuracy and comparability. GAIA has prepared draft guidelines – “Guidelines for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women” on prioritizing data to be collected in studies of the use of vaccines in pregnancy, and to assist their applicability in various geographical, cultural and resource settings, including LMICs. The Global Alignment of Immunization safety Assessment in pregnancy (GAIA) network was formed to help establish a global, common understanding of outcomes and approaches to monitoring safety of vaccines used in pregnancy with particular focus on LMICs. The consultation also recommended developing a guidance document for data collection, analysis and presentation of safety data, tools for harmonized data collection, data sharing, and the use of health-care data sets to strengthen safety surveillance. In 2014, WHO convened an expert consultation to a) review existing obstetrical and paediatric adverse event case definitions and guidance documents b) prioritize terms for key events for continuous monitoring of vaccine safety in pregnancy c) develop concept definitions for these events and d) recommend a core data set of key terms of events to be collected when monitoring safety of vaccines used in pregnancy. Thus, the harmonization of terms, disease concepts and the use of standardized case definitions of key events related to safety monitoring of vaccines will facilitate comparability of outcomes across studies. However, due to the heterogeneity in the definitions of terms used to assess vaccine safety, data collection methods and their presentation, comparing results across studies and settings presents challenges. ![]() Vaccination during pregnancy offers mothers and their infants effective protection against infectious diseases. Extract from GACVS meeting of 15-16 June 2016, published in the WHO Weekly Epidemiological Record of 15 July 2016
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |