Pregnancy and Lactation Studies
Improving health and safety during pregnancy and lactation
It is estimated that 70% of pregnant people and at least 50% of lactating people take medications for short-term or chronic conditions that require ongoing treatment such as asthma, high blood pressure and depression.1
However, these populations are generally excluded from clinical trials, leaving patients and providers with insufficient data and little guidance as they assess the benefits and risks of medications.
Increasing the availability of pregnancy and lactation studies is essential to ensuring optimal care for pregnant and lactating people and their infants. With the growth of emphasis and guidance on post-approval safety studies by regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), there has been an increase in studies undertaken to understand the safety and efficacy of medications, treatments and interventions in these subpopulations.
By exploring and addressing the unique challenges and complexities associated with pregnancy and lactation studies, we enable our clients to improve patient outcomes, inform clinical practice, and enhance the overall health of women and their babies around the world.
Considerations for lactation studies during drug development
Explore the wide range of pregnancy and lactation studies currently enrolling participants
Specialized solutions for special populations
Pregnancy and lactation studies present specific challenges that require specialized knowledge. Deliver on your business goals and address regulatory requirements with fit-for-purpose solutions designed to meet your study’s needs. With solutions tailored to provide high-quality, reliable data while minimizing the burden on participants, we enable our clients to move their products forward with evidence regarding the safety and efficacy of medications, treatments and interventions during pregnancy and lactation. Working in partnership with our clients, we equip health care providers (HCPs) and patients with comprehensive information, empowering them to make informed decisions.
Gain confidence in the relevance and applicability of the data collected and its ultimate impact on the health of pregnant and lactating persons, their infants, and future generations with our comprehensive, customized approach.
Pregnancy exposure registry solutions
Prospective in nature, pregnancy exposure registries actively engage pregnant and lactating people and their HCPs to capture data throughout pregnancy and the first year of the infant’s life. These studies can efficiently satisfy regulatory post-marketing requirements through a variety of registry options, including:
Single product and single protocol registries designed to your specific product/study needs
Multi-product and multi-protocol consortia, which maintain the individuality of a single product/single protocol registry while enabling collaborative opportunities between sponsors (e.g., sharing comparator data) with consistency across protocols, statistical analysis plans, etc.
Independent multi-product single protocol registries that enhance efficiency in meeting post-marketing commitments (PMCs) and post-marketing requirements (PMRs) by utilizing shared resources, such as comparators, tools and processes through an integrated registry under a single protocol
Health care database pregnancy studies
Retrospective in nature, health care database pregnancy studies use existing secondary data collected in the usual course of care, accessed through de-identified databases that represent large populations of patients. These studies:
- Require the availability of reliable exposure data suitable for pregnancy studies in secondary databases
- Typically can be conducted with reduced timelines and budgets as compared to prospective studies
- Enable data collection in situations involving small populations of exposed individuals
- Can be delivered as stand-alone studies or as part of a program offering with a complementary or parallel exposure registry
Descriptive pregnancy safety studies
Designed for products expected to have rare pregnancy exposures, a descriptive pregnancy safety study is a global surveillance program that collects worldwide prospective and retrospective data in people exposed to a product during pregnancy. The study assesses:
- Risk of pregnancy and maternal complications
- Adverse effects on the developing fetus and neonate
- Adverse effects on the infant through at least the first year of life
Lactation safety studies
Designed specifically to monitor the transfer and absorption of the study drug to infants through lactation. There are several study options depending on study goals, including:
- Milk-only studies, which detect the presence and quantity of the study drug in breast milk. These are recommended in most cases.
- Milk plus serum studies, which provide pharmacokinetic (PK) data on a drug in breast milk and in serum/plasma, and directly measure the amount of drug transferred in breast milk. These are used when PK data of the drug in lactating women is unknown and/or to assess for potential drug accumulation in breast milk.
- Pair mother-infant studies, which provide direct assessment of drug absorption in infants. These are suggested if drug transfer data exist and evidence shows accumulation and potential absorption by the infant.
Pregnancy and lactation studies for research questions beyond safety
While pregnancy and lactation studies are most often focused on safety, they can also answer other research questions in this population. Gather real-world evidence to support product development through studies such as:
Pregnancy and lactation programmatic delivery approach
Benefit from a holistic delivery approach for two or more pregnancy and/or lactation studies that are required for the same asset. We offer a multi-study solution that incorporates a programmatic approach, delivering:
- Consistency: Harmonize global programs with consistent submissions, regulatory interactions and study terms and definitions across studies
- Efficiency: Maximize efficiencies for operational excellence with common documents, processes and knowledge sharing around the study drug
- Cohesiveness: Align your entire pregnancy and lactation program and receive cohesive delivery with holistic program oversight
- Expertise and accountability: Increase confidence in your pregnancy and lactation program by partnering with a dedicated, cross-functional team of experts to shape your strategy and study design and provide quality delivery
Benefit from global experience
Enhance strategic planning, streamline delivery, and optimize study efficiencies to effectively meet research needs by leveraging our global pregnancy and lactation study experience. Improve the speed and accuracy of your study with access to innovative technologies designed to minimize patient and physician burden, enhance retention rates, and elevate data quality.
We deliver customized, high-quality study designs, proprietary data solutions and operational excellence for your pregnancy and lactation studies. Our collective experience and resources include:
- Expansive breadth and depth of scientific and operational expertise and knowledge of pregnancy and lactation studies, enabling an integrated approach for full-service delivery
- Unique ability to identify and bring together sponsors of individual bespoke pregnancy registries into a consortium for existing and future pregnancy registries focused on the same disease
- Exclusive provider of an innovative solution for the conduct of independent pregnancy exposure registries, enabling our clients to most efficiently satisfy their post-approval safety study requirements by leveraging shared resources and benefiting from the credibility of an independently run study
- Extensive knowledge of real-world data sources across the U.S., Europe and parts of Asia-Pacific, enabling us to evaluate and advise on the most suitable, fit-for-purpose data to optimize study design and execution
In the past five years, we’ve partnered with developers on:
Safety studies and program
Lactation studies (Phases I-IV)
Pregnancy exposure registries, including 4 multi-product registries
Optimized recruitment for prospective pregnancy and lactation studies
Finding and recruiting the right participants for your pregnancy and lactation study can be a challenge. These populations can be particularly challenging to recruit given inherent participant concerns about their well-being and the health and safety of their fetus or infant.
We offer flexible, innovative solutions for reaching, recruiting and retaining this special population, including:
- A virtual research coordination center offering comprehensive participant-centric solutions that reduce burden to improve retention
- A central primary investigator model that allows a study to be fully decentralized in applicable countries, bringing the study directly to patients while reducing burden, site footprint and site-based costs
- Fully dedicated, in-house board-certified consultants in obstetrics, gynecology and neonatology who cultivate personalized relationships with patients and health care providers to enhance enrollment and retention
Achieve expedited recruitment through our custom strategies, reaching up to 90% of first-time expectant mothers in the U.S. and more than 37 million globally.
Meet participants where they are with virtual studies
Optimize the participant experience with virtual pregnancy and lactation studies that minimize delays and inconvenience by allowing patients to visit a local care hub or arrange for a nurse to make home visits. Participants in studies requiring intensive monitoring or clinical procedures have access to a patient concierge who proactively assists with resources and solutions to reduce the burden for patients and their caregivers, and in-clinic domiciling if needed.
Bring clinical research to the patient with our digital and decentralized trial technologies, meeting them where they are and simplifying participation through the use of mobile sites, wearables, telehealth and e-consent, for example.
Pregnancy and Lactation Center of Excellence
The PPD™ Pregnancy and Lactation Center of Excellence (COE) brings together a distinguished group of interdisciplinary experts committed to providing thought leadership and guidance to address specific research needs in pregnancy and lactation. With a focus on establishing and promoting best practices, our team shapes optimal study design, strategy and execution, drawing upon decades of collective knowledge and experience. This cross-functional team of experts delivers innovative, patient-centric recruitment and retention solutions to optimize study efficiency and success.
Through the collaborative platform of our COE, we foster interdisciplinary relationships, facilitate knowledge exchange and promote innovation in the field of pregnancy and lactation studies. We are committed to supporting you in advancing the understanding of maternal and fetal health, improving patient outcomes and contributing to the well-being of pregnant and lactating individuals worldwide.
As leaders in this field, our experts have shared their work and insights in more than 270 publications and presentations and have been invited to consult by organizations such as the FDA, World Health Organization and the Centers for Disease Control and Prevention. Through invaluable insights, our COE provides clients with unparalleled expertise and advantages in this field.
