Recent moves by the U.S. Federal Drug Administration (FDA) to open clinical studies to real-world evidence (RWE) based on real-world data (RWD) have had an important beneficiary: babies. Most clinical studies intentionally exclude pregnant women from clinical drug trials due to safety and ethical concerns. Fortunately, real-world evidence provides new opportunities to ethically and effectively study pregnant mothers and their children, which has resulted in the rapid adoption of post-approval pregnancy studies.
Collecting healthcare data on pregnant mothers is not a new phenomenon. For many years, clinical research organizations and trial sponsors have relied on self-reporting registries to track the effects of drugs on pregnant women and their children. While disease registries continue to be an important source of post-approval pregnancy data, they are no longer the only source of data. Real-world data drawn from insurance claims, electronic health records (EHR), and other point-of-care data sources, plays a complementary and critical role in measuring the effects of drugs on pregnant women and their babies.
Real-world data is giving life sciences companies a deeper understanding of how medications and treatments affect pregnant mothers and their babies. However, not all data provides the same level of insight. For example, while most pregnancies are well chronicled through prenatal visits, once the baby is born, it can be difficult to link mother and child healthcare encounters because EHRs treat individuals as separate entities. Pairing mother and child patient data within a family, which is more commonly possible through insurance claims data, can offer valuable insights into whether health conditions are related to prior treatment or drug interactions.
Having the ability to track patient outcomes across healthcare systems provides healthcare experts with critical insights to inform patient care and ultimately drug development. While it is important to know when health problems arise for a mother or child, it is equally important to know when problems do not occur. Many RWD systems adequately collect healthcare encounters when they occur (I.e., office visit, prescription), but are not comprehensive enough to conclusively determine that no additional healthcare encounters occurred. To do this, the data collection needs to be part of a closed system that captures all patient encounters and not just those that occur within a particular clinical practice or pharmacy chain.
Data longitudinality is another important consideration when assessing the strength and value of sources of RWD for post-approval pregnancy studies. Starting from the pre-pregnancy exposure period, through a full-term pregnancy, and ultimately through at least one-year (and often more) of infant healthcare encounters requires a study observation period of at least two years and often spans three separate insurance plan years. During this period, an individual may change insurance carriers, making it difficult to track their experiences consistently over time. For this reason, employer-based insurance data yields the best chances of capturing outcomes across an individual’s lifecycle. Adults are less likely to switch jobs than to switch insurance carriers, and even if their employer switches to a different health plan, they continue to collect patient data across the continuum of care.
Leveraging comprehensive, employer-sourced RWD enables organizations to uncover more advanced RWE insights by pairing patient records and conducting outcomes research over a longer period. As RWE studies grow more widely accepted, we are seeing more clinical trial stakeholders and regulators using it to improve decision-making, inform regulations, and augment clinical studies. For years, clinical trials have had to exclude a group that is highly vulnerable to drug complications, pregnant women. Now, thanks to advancements in RWD and RWE studies, those same trial sponsors can actively study and protect pregnant women and their babies through robust outcomes research.
Our researchers have had the honor to have a seat at the table for nearly three decades, helping strengthen, accelerate, and simplify RWE studies with MarketScan. We have a passion for helping life sciences companies address a spectrum of regulatory issues including orphan drug designation, external control arms, pregnancy-exposure, and adverse event/signal detection analyses.
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