Improving Medicine Use During Pregnancy & Breastfeeding: Forging a Path Forward   

The scientific community intended to protect pregnant and breastfeeding populations when it strictly limited their involvement in clinical trials after the thalidomide crisis of the 1950s-1960s. Yet over the past few decades, people have increasingly recognized the real-life challenges posed by the lack of research into the safety of medications used during pregnancy and breastfeeding.

Two groups that are keenly aware of how these challenges impact pregnant and breastfeeding individuals include:

• the team studying global regulations governing the use of medicines in pregnancy and breastfeeding as part of TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative.
• the ConcePTION project, a private public partnership funded by the Innovative Medicines Initiative, to establish a trusted ecosystem that can generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers.

In this fourth installment of our IGR PV blog series, we’ll take a closer look at some of the complementary work of these two projects and why it’s so important.

Aligned efforts, different approaches

According to the ConcePTION project, up to 90% of women take medications at some point during pregnancy or when breastfeeding, yet less than 4% of medicines are explicitly labeled as safe to use. The dearth of research means that women and their physicians have very little information on which to make informed, evidence-based medication decisions.

Fortunately, organizations such as TransCelerate and ConcePTION are helping to change that trajectory. The TransCelerate IGR PV topic team’s work has dovetailed nicely with the ConcePTION consortium’s efforts.

Both groups understand that pregnant and breastfeeding populations present a unique clinical scenario. Studies must be designed to provide evidence which can inform medication risk/benefit analyses for not only one person but two, a mom and a baby, that may have slightly different risks and benefits. So, improving the evidence quality and available regulatory guidance is vital to help healthcare professionals inform and safeguard these vulnerable patients.

With that thought in mind, the two groups aspire to do similar things but in a different fashion. One is more scientific, while the other comes from a regulatory standpoint:

• TransCelerate’s IGR PV topic team has looked across regulatory guidance to see how they differ, how they are similar, and whether guidance even exists. 
• ConcePTION was designed to gather, in a structured way, all the pockets of good epidemiological PV research throughout the European Union (EU). It seeks to create a pan-European ecosystem with best practices and scientific rigor.

The two projects supplement each other. For example, within ConcePTION, two Work Packages have endeavored to establish 1) core data elements for population-based pregnancy safety studies and 2) core data elements for primary data collection in pregnancy safety studies. Work Package 2 further hopes to provide a framework to help guide how core data elements should be statistically analyzed and ultimately reported, aiming to bring the data and evidence base together more succinctly. The group hopes its Delphi review of the statistical analysis and reporting recommendations will be published soon.

Meanwhile, knowledge of the two Work Packages informed efforts by TransCelerate’s IGR PV topic team to see whether the core data elements are mentioned in regulations and incorporated into “best practice” guidelines. The TransCelerate team has also asked sponsor companies about their use of the ConcePTION core data elements for post-marketing studies.

Likewise, the IGR PV team shared with ConcePTION its peer-reviewed Landscape Assessment document, which reveals some of the existing regulatory gaps. The landscape assessment supported another facet of the ConcePTION project aimed at trying to set up a scientific underpinning for how to potentially influence regulatory guidelines—or even provide guidelines where they haven’t previously existed.

Advancing science together

Both projects have unified many who are passionate about advancing science to aid mothers and babies. People from public organizations, academic institutions, and multiple pharmaceutical companies have all worked in concert. The true benefit of this collaborative approach is that everyone better understands the challenges others face, and the insights others have garnered. This understanding is an invaluable foundation for building bridges and fostering scientific improvement.

Still, the current body of work is just a first step in many ways. TransCelerate’s IGR PV topic team views it as a call to action—recognizing the need to evaluate and harmonize global standards, regulations, and guidelines. But with this first step, the science starts to come together.

Ultimately, the hope is to provide better-quality data faster to help close gaps and address the medication safety needs of pregnant and breastfeeding women. With faster access to larger volumes of rigorous data, everyone can make more informed decisions—sponsors, healthcare professionals, patients, and their families. 

To learn more about TransCelerate’s IGR PV team, stay tuned for the final blog in our IGR PV series and discover what’s on the horizon for Topic 7 and ICH E21.

To access our entire suite of IGR PV solutions, see the IGR PV solutions page.

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