Adoption and use of real-world data (RWD) for decision-making has been complicated by
concerns regarding whether RWD was fit-for-purpose or was of sufficient validity to support …

Purpose Perinatal epidemiology studies using healthcare utilization databases are often
restricted to live births, largely due to the lack of established algorithms to identify non‐live …

There is a dearth of safety data on maternal outcomes after perinatal medication exposure.
Data-mining for unexpected adverse event occurrence in existing datasets is a potentially …

There is growing interest in the secondary use of health care data to evaluate medication
safety in pregnancy. Tree-based scan statistics (TBSS) offer an innovative approach to help …

Background Despite the prevalence and negative impact of posttraumatic stress disorder
(PTSD), there are few medications approved by the US Food and Drug Administration for …

Many examples of the use of real-world data in the area of pharmacoepidemiology include
“big data” such as insurance claims, medical records, or hospital discharge databases …

Purpose To elucidate the status of medication use among pregnant women in Japan, by
means of a multigenerational genome and birth cohort study: the Tohoku Medical Megabank …

Purpose It is a priority of the US Food and Drug Administration (FDA) to monitor the safety of
medications used during pregnancy. Pregnancy exposure registries and cohort studies …

Genomic surveillance data are used to detect communicable disease clusters, typically by
applying rule-based signaling criteria, which can be arbitrary. We applied the prospective …

Purpose Signal detection is a crucial step in the discovery of post‐marketing adverse drug
reactions. There is a growing interest in using routinely collected data to complement …