Background: In the context of an EU post-approval regulatory commitment to provide missing information on a COVID-19 pre-exposure prophylaxis (PrEP) and safety in pregnancy, existing healthcare databases could serve as a useful data source. Prior to conducting an observational study, a fit-for-purpose (FFP) data assessment should be performed to assess the relevance of use of data sources.
Objectives: To conduct a FFP assessment among existing healthcare databases to study pregnancy and offspring outcomes in a population of women diagnosed with high-risk conditions exposed to COVID-19 PrEP.
Methods: A global data landscape was performed to identify existing databases capturing pregnancy outcomes and treatment exposures in 11 countries using peer-reviewed publications, grey literature and relevant publicly available inventories. A screening was conducted to select candidate data sources for the FFP assessment based notably on data source reliability and lag, mom-baby linkage and capture of COVID-19 PrEP. The structured process for identifying fit-for-purpose data (SPIFD) was used for the FFP assessment, which operationalized the minimum data criteria, assessed the data availability, and assigned a FFP ranking across each of the study design characteristics in relation to the proposed research question.
Results: During the landscape search, 51 databases were identified ranging from prospective cohorts, single centers, medical administrative claims, pregnancy registries and electronic medical records. The US had the largest number of databases (n=3) and European countries had a limited number (n=1-3) of unique databases per country. After screening, 8 databases among the 51 databases identified (16%) were selected for the FFP assessment. The most common reasons for exclusion included lack of relevant data and declining to further participate mainly due to low sample size. Among the 8 databases assessed, only 1 European database was considered FFP for studying COVID-19 PrEP exposure in women with high-risk conditions. To further complement the single European cohort, 2 non-European databases part of the assessment (Canada and US) were identified as FFP. A combination of low sample size along with lack of capture of relevant treatment data elements led to low FFP rankings across the other databases assessed.
Conclusions: Identifying FFP databases with sufficient population size and data relevance to study the pregnancy and offspring safety outcomes after a COVID-19 PrEP exposure is challenging. A combination of European and non-European data sources is required to study low drug exposure and such outcomes.
