Advancing Pregnancy Safety: The Critical Role of Collaboration in Exposure Registries

Examining the intricacies of pregnancy exposure registries including insights into development, challenges and importance of collaboration.

Pregnancy exposure registries are pivotal in ensuring the safety of medications for pregnant women and their babies, particularly as more women manage chronic conditions during pregnancy. In a recent Syneos Health webinar, experts from epidemiology, industry, and healthcare delved into the intricacies of multi-sponsor pregnancy exposure registries, offering critical insights into their development, challenges, and the importance of collaboration.

The Shifting Landscape of Pregnancy and Medication

Over the past three decades, the median age of childbirth in the US has risen from 27 to 30 years, according to research from the US Census Bureau. This shift has brought an increase in chronic conditions, such as hypertension and autoimmune disorders, among expectant mothers. Managing these conditions often requires medications, making it essential to balance maternal and fetal health risks.

However, providers face significant challenges in accessing reliable safety data on medication use during pregnancy. A study conducted in 2023 revealed that only 12 of 155 FDA post-marketing studies produced publicly available safety data—a stark reminder of the urgent need for efficient, high-quality research.

Collaboration in Action: The Multi-Sponsor Model

The Antiretroviral Pregnancy Registry (APR), established in 1989, exemplifies how multi-sponsor collaboration can overcome these challenges. With data from over 27,000 pregnancies across 75 countries, the APR has become a vital resource for evaluating the safety of more than 200 drugs used in HIV and Hepatitis B treatment and prevention. Its governance structure, combining advisory committees, sponsor representatives, and a coordinating center, ensures robust and unbiased data collection and dissemination.

This model demonstrates the potential of multi-sponsor registries to address knowledge gaps, expedite data collection and provide actionable insights for healthcare providers and regulators.

Collaborative efforts not only accelerate data collection but also ensure that findings are actionable, benefiting both patients and providers...

• Pregnancy exposure registries require meticulous planning and alignment with regulatory standards like those outlined by the FDA and EMA. Key considerations include methodological rigor (including the use of internal comparators), compliance with diverse regulatory and ethical standards, and clear governance structures to balance scientific, operational and financial activities.
• Professional organizations play a crucial role in raising awareness of registries and incorporating findings into clinical guidelines. The inclusion of registry data in resources like the American College of Obstetricians and Gynecologists’ guidelines on mental health medications underscores their growing acceptance.
• Despite their importance, registries often struggle with low enrollment. Strategies like leveraging digital tools (e.g., pregnancy tracking apps), patient support programs and academic partnerships can enhance participation.
• The 2019 FDA guidance on postapproval pregnancy safety studies encourages collaborative, multi-product registries and alternative data sources, marking a shift toward a more integrated research approach. However, gaps in guidance remain in areas like duration of infant follow-up and ongoing breastfeeding exposure.

Looking Ahead: Opportunities for Registry Data Growth

As Jessica Albano, VP of Epidemiology at Syneos Health, noted during the webinar, "collaborative efforts not only accelerate data collection but also ensure that findings are actionable, benefiting both patients and providers.”

The evolving regulatory landscape and advancements in data collection methodologies present opportunities to enhance the impact of pregnancy exposure registries. By fostering collaboration, leveraging digital technologies, and addressing existing gaps, the industry can continue to improve the safety and efficacy of medications for expectant mothers.

Watch the full webinar for more information on the importance of pregnancy registries.

Contributors 

Jessica Albano, PhD | Vice President, Epidemiology

Sara Ephross, PhD | Senior Director Epidemiology

Sigal Kaplan, PhD | Director, Pharmacoepidemiology Leader at Teva Pharmaceutical Industries Ltd.

Laura McKain, MD | Board-certified Obstetrician and Gynecologist

Sources

Albano JD, Scheuerle AE, Watts DH, Beckerman KP, Mofenson LM, Pikis A, Vannappagari V, Seekins D, Cook TS, Tilson H; Antiretroviral Pregnancy Registry Steering Committee. The Antiretroviral Pregnancy Registry: Three decades of prospective monitoring for birth defects. Pharmacoepidemiol Drug Saf. 2024 Jun;33(6):e5801. doi: 10.1002/pds.5801. PMID: 38798093.

Chaffin K, Horvath A, Gullett S, Christian G, McKain L. Pregnancy drug exposure safety studies: an analysis of FDA post-approval requirements and commitments. Presented at: American Medical Writers Association (AMWA) Annual Meeting; March 2023.