Call To Include More Pregnant And Breastfeeding Women In Research

A conversation with Marie Teil, global head, women of childbearing age program, UCB

A scan of inclusion/exclusion criteria on a handful of studies on clinicaltrials.gov makes one thing apparent: If you’re pregnant or breastfeeding, there’s a good chance you won’t qualify for a clinical trial. Quite often, women of childbearing age (WoCBA) find themselves ineligible for trials based on their status of being pregnant or breastfeeding, and thus a scarcity of data exists for this particular subset of the population. 

Despite an endorsement in 2018 by a U.S. Department of Health and Human Services task force “to emphasize the importance and public health significance of building a knowledge base to inform medical decision-making” for pregnant and lactating women and no longer describing pregnant women as a “vulnerable population” in the Common Rule a year later, advocates are still having to argue for more pregnant and breastfeeding women to be included in clinical research. 

In this Q&A, UCB Global Head, Women of Childbearing Age Program Marie Teil reiterates the importance of including WoCBA in clinical research and explains the UCB commitment.

Clinical Leader: When it comes to clinical trial data, is the data lacking for all women or specifically WoCBA?

Marie Teil: The challenge of low participation in clinical trials affects all women, particularly those who are of childbearing age, pregnant, or breastfeeding. This could have serious consequences for those who are taking medication for chronic diseases and are considering pregnancy. Studies show that more than 80% of pregnant patients are routinely prescribed therapies that have not been studied during pregnancy and/or lactation.3

Yet, even today, clinical trials for chronic conditions often exclude women at various stages of their reproductive journey. Many clinical trials require women to use contraception or to be withdrawn from the study if they become pregnant, leaving women with chronic diseases without clear information on the benefits and risks of their medications.

Pharmaceutical companies often invest less in trials focused on women of childbearing age, pregnant women, or lactating women due to concerns about liability and risks. For women of color, the disparities are even more pronounced, with Black, Asian, and ethnic minority women being less likely to be included in health research.

In what therapeutic area (TA) is the paucity of clinical trial data from women/WoCBA most prevalent? Where is it richest? And in what TA do we stand to gain the most ground?

The paucity of clinical trial data from women sits across all therapeutic areas. Although there is still room for improvement, it seems that the richest data tends to be in therapeutic areas where there has been a concerted effort to include women in clinical trials, such as certain cancers, HIV, and reproductive health.

Conversely, the data gap is most prevalent for conditions where women are impacted differently, such as cardiovascular disease and neurological disorders, where gender differences can significantly affect disease presentation and treatment outcomes.

Other therapeutic areas where we stand to gain the most ground are those where women are disproportionately affected compared to men, such as dementia and autoimmune diseases. For example, women account for around 80% of all cases of autoimmune diseases.

What are some long-standing beliefs about women participating in clinical trials that have since been discredited?

It was once believed that hormonal changes in women, particularly those of childbearing age, would complicate clinical trial results. However, this has been discredited as novel research methods can account for these variations, and excluding women leads to a lack of data on how treatments affect them.

Another outdated belief is that women are less reliable participants due to potential pregnancy or caregiving responsibilities. This has been disproven as women have shown high levels of commitment and reliability in clinical trials when appropriately supported.

Both industry and academia assumed that findings from male-dominated studies could be universally applied to women. This has been debunked; sex and gender differences can significantly impact how medical conditions affect a person as well as the efficacy and safety of treatments. 

What are some still-standing truths regarding WoCBA inclusion, and how do we ensure protection as we aim to increase WoCBA inclusion?

For one, women worry about risks to their reproductive health. Ethical guidelines and regulatory requirements mandate the protection of WoCBA in clinical trials. This includes informed consent processes that clearly communicate potential risks and benefits. Women must have specific information about how trials affect their health. It is crucial to gather gender-specific data to understand how treatments affect women differently from men. Finally, trust plays a crucial role in a patient’s decision to participate in a clinical trial. Women need to feel confident that their healthcare providers are knowledgeable, supportive, and have their best interests at heart.

We should ensure protection for WoCBA by providing information that is clear, comprehensive, and tailored to the specific concerns of WoCBA. This includes potential risks, benefits, and the measures in place to protect a woman’s health. Clinical trials also can be designed to accommodate the unique needs of WoCBA with flexible scheduling, homecare, and additional health monitoring to make participation more feasible and less stressful. It is crucial to adhere to ethical guidelines and ensure that women are fully informed about their rights and the protection in place. This includes obtaining informed consent and respecting their autonomy throughout the trial.

How can pharma companies more accurately understand the true risk or liability of involving more WoCBA in clinical trials?

It’s a cross-functional collaboration: We must engage various stakeholders, including clinical researchers, regulators, ethicists, and patient advocacy groups, to develop a comprehensive understanding of the risks and to create strategies for mitigating them.

Congress recently called on The National Academies of Sciences, Engineering, and Medicine to assemble a committee to study the actual and perceived risks of liability surrounding research conducted with pregnant and lactating women. The National Academies issued an informative report, “Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks” that showed the “limited evidence of legal liability for the inclusion of pregnant and lactating women in clinical research,” which contradicts existing perceptions and fears of increased liability. The committee also provides recommendations to improve the evidence base concerning the safety and efficacy of medications for pregnant and lactating women, thereby facilitating more informed decision-making regarding care while reducing liability.

By integrating these recommendations, pharma companies can better understand and manage the risks associated with including more WoCBA in clinical trials, ultimately leading to safer and more effective treatments for all patients.

How has UCB begun to include more WoCBA in its clinical trials?

UCB was the first pharmaceutical company to conduct clinical research and generate strong evidence in women with chronic inflammatory diseases during pregnancy and breastfeeding. Our work at UCB started about 10 years ago, and we’ve made it our mission to empower women with chronic diseases to make informed decisions about their healthcare. This systematic approach is embedded across early drug development, late-stage, and in-market disease areas: 

• We assembled a cross-functional team of experts within our organization to systematically assess women’s unmet needs during their reproductive journey in all our therapeutic areas.
• We design studies with women in mind. In collaboration with our women patient experts, we have operationalized a remote enrollment model to reduce the burden of clinical studies. 
• Furthermore, our clinical trial protocol templates allow women who become pregnant during a trial to remain in the study, which they usually do. 

UCB is committed to generating new data for women. Our pregnancy registries are also generating new data to advance the care of women of childbearing age with chronic diseases. We acknowledge the collaborative nature of our work, and we recognize that a sustainable impact cannot be achieved in isolation. This is why we partner with patients, scientific communities, regulators, and policymakers to advance the scientific understanding of women of childbearing age with chronic diseases.

Our commitment doesn’t stop there. UCB is involved in initiatives like ConcePTION, which aims to reduce uncertainty about the effects of medications used during pregnancy and breastfeeding, and PRGLAC, which advises on research gaps for pregnant and lactating women. UCB is also a member of a working group within the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH initiative) to develop harmonized guidelines to enable the inclusion of pregnant and breastfeeding individuals in clinical trials. Additionally, UCB is working with TransCelerate to collaborate on common drug development challenges, such as improving data quality, sharing knowledge and resources, and enhancing medical research practices. The organization aims to accelerate drug development in a safe, ethical, and cost-effective manner for the benefit of patients.

What can other pharma companies do to follow the same trajectory?

Organizations must prioritize engaging women throughout all phases of research, ensuring that their needs and experiences directly shape the studies. It is particularly important to overcome long-standing ethical barriers that have often excluded pregnant and breastfeeding women from clinical trials. We now know that we should protect women through research and not from research.

Having clear, precise communication about the risks and benefits of treatments ensures that both participants and healthcare providers have accurate information. Developing thoughtful dissemination strategies ensures that research results reach all relevant stakeholders, from patients to policymakers, ultimately enhancing the impact and inclusiveness of medical research.

We strongly believe that we should accelerate our efforts for these women, who are often diagnosed during their childbearing years and for whom the wish to build a family, be pregnant, or breastfeed is still challenging. 

Access to accurate, evidence-based health information is a fundamental right for every woman. Women should lead the way in making decisions about their health, and it’s our collective responsibility to make this vision a reality.

About The Expert:

Marie Teil is a pharmaceutical executive with 20+ years of experience in the health field, with roles ranging from academia and clinical research to ethics and operations. She joined UCB with a visionary purpose — to establish the Women of Childbearing Age program. Her mission was to push the boundaries of science and elevate the standard of care for women facing chronic diseases during their childbearing years. 

As a woman and mother, Marie is dedicated to advancing science in women’s health. She believes that by collaborating with patients, HCPs, regulators, and advocacy groups, we can create a more inclusive and patient-centric approach to drug development and clinical care. 

In addition to her UCB work, she co-chairs BRIDGE (Better Research, Information and Data Generation for Empowerment) — a global independent commission committed to advancing practical and action-oriented solutions to overcome information gaps that affect women’s health before, during, and after pregnancy.