Including pregnant women in drug trials can lead to better health outcomes and reduce misinformation, experts say – WHYY

Report on the Inclusion of Pregnant and Lactating Women in Clinical Research to Advance Sustainable Development Goals

Introduction: Addressing a Critical Gap in Global Health

The historical exclusion of pregnant and lactating individuals from clinical drug trials has created a significant information deficit, undermining progress towards key Sustainable Development Goals (SDGs), particularly SDG 3: Good Health and Well-being. This lack of research compromises the health of both mothers and children, creating obstacles to achieving universal access to safe, effective, and quality medicines as outlined in Target 3.8. Recent discourse, reignited by public health announcements, emphasizes the urgent need to shift from a policy of exclusion to one of protection through research, ensuring maternal and child health are not mutually exclusive priorities.

Historical Context and Impact on Health Equality

The practice of excluding pregnant women from clinical trials is rooted in safety concerns, notably amplified by the thalidomide tragedy of the 1950s and 1960s. While intended to protect the fetus, this extreme caution has inadvertently created significant risks by leaving healthcare providers and patients without evidence-based guidance on medication use during pregnancy.

Consequences for SDG 3 (Good Health and Well-being)

• Information Voids: The absence of robust clinical trial data means that much of the current knowledge is derived from retrospective studies and data registries. This reactive approach is insufficient for proactively ensuring the health of mothers and newborns, directly impacting Target 3.1 (reduce maternal mortality) and Target 3.2 (end preventable deaths of newborns).
• Risks for Women with Chronic Conditions: Women with pre-existing conditions such as hypertension, diabetes, or mental health disorders face a difficult choice between managing their own health and potential unknown risks to their pregnancy. Discontinuing necessary medication can be harmful to both mother and fetus, highlighting a critical failure in providing comprehensive healthcare for all.

Implications for SDG 5 (Gender Equality) and SDG 10 (Reduced Inequalities)

The systematic exclusion of this population from medical research constitutes a form of gender-based inequality in healthcare. It denies pregnant individuals the autonomy to make informed decisions about their health and participate in research that could benefit them and future generations. This practice perpetuates a systemic disadvantage, running counter to the principles of SDG 5 (achieve gender equality) and SDG 10 (reduce inequality within and among countries).

Policy Reform and Institutional Efforts for Inclusive Research

A growing consensus among leading medical organizations and federal bodies advocates for the ethical and appropriate inclusion of pregnant and breastfeeding people in drug research. This movement seeks to build stronger, more inclusive health systems in line with SDG 16: Peace, Justice and Strong Institutions.

Key Recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women

A 2016 federal law established a task force to address these research gaps. Its final report outlined several key recommendations to align research practices with global health and equality goals:

1. Declassify Pregnant Women as a “Vulnerable Population”: Re-categorizing this group in research regulations would facilitate their inclusion and uphold their autonomy, directly supporting SDG 5 by challenging discriminatory classifications.
2. Prioritize and Fund Research: Develop and support programs focused on creating treatments specifically for conditions arising during pregnancy and lactation. This is essential for achieving the health targets of SDG 3.
3. Expand the Specialized Workforce: Increase the number of clinicians and researchers specializing in obstetric and lactation pharmacology to build institutional capacity for this critical area of health.

Conclusion: A Path Forward for Equitable Maternal Health

Integrating pregnant and lactating women into clinical research is not merely a scientific imperative but a crucial step toward achieving global sustainable development. By closing the evidence gap, the medical community can better support the health of mothers and children, advance gender equality in healthcare, and build more resilient and equitable health systems. This paradigm shift is fundamental to fulfilling the promise of the Sustainable Development Goals, ensuring that no one is left behind in the pursuit of health and well-being for all.

Analysis of SDGs, Targets, and Indicators

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being

  The article’s central theme is the health of pregnant women and their children. It discusses the lack of research on medication safety during pregnancy, which directly impacts the ability to manage chronic diseases, mental health conditions, and other health issues, thereby affecting the well-being of both mother and fetus. The historical thalidomide incident, which caused “serious birth defects in infants,” is a stark example of the health consequences addressed.

• SDG 5: Gender Equality

  The “historical exclusion” of pregnant women from clinical trials represents a significant gender-based inequality in healthcare research. The article points out that this exclusion denies women the ability to make informed decisions about their health and perpetuates a system where their specific health needs are under-researched. The push to “move away from automatic exclusion” and “protect women through research” is an effort to achieve greater equality in medical science.

• SDG 10: Reduced Inequalities

  This goal is relevant as the article focuses on the inequality faced by a specific population group—pregnant and lactating women—in the context of medical research and healthcare. The recommendation from the Task Force to “declassify pregnant women as a ‘vulnerable population’ in research regulations” is a direct attempt to reduce this inequality and ensure they have the same opportunities to benefit from scientific advancements as other groups.

2. What specific targets under those SDGs can be identified based on the article’s content?

1. SDG 3: Good Health and Well-being

   • Target 3.1: By 2030, reduce the global maternal mortality ratio.

     The article supports this target by emphasizing the need for safe and effective treatments for conditions like “hypertension or diabetes or Crohn’s disease” during pregnancy. It states that “not being on your medicines when you’re pregnant is actually quite harmful, not just to you, but also to the pregnancy,” highlighting that proper, evidence-based medical care is essential to prevent complications that could lead to maternal mortality.

   • Target 3.2: By 2030, end preventable deaths of newborns and children under 5 years of age.

     The thalidomide tragedy, where an untested drug caused “10,000 and 20,000 babies worldwide” to be born with severe defects, directly relates to this target. The push for including pregnant women in trials aims to prevent such outcomes by ensuring medications are safe for the fetus, thereby reducing preventable infant harm and mortality.

   • Target 3.8: Achieve universal health coverage, including access to safe, effective, quality and affordable essential medicines for all.

     The core issue of the article is the “gap in research on which medications are indeed dangerous, or safe” for pregnant women. This gap means this population lacks access to medicines that are proven to be “safe, effective, [and] quality.” The effort to increase research aims to ensure this group is not left out of universal health coverage concerning essential medicines.

2. SDG 5: Gender Equality

   • Target 5.1: End all forms of discrimination against all women and girls everywhere.

     The “historical exclusion” of pregnant women from clinical trials is a form of systemic discrimination. The article notes the need to shift to a culture that “protects women through research,” rather than excluding them, which aligns with ending discriminatory practices in science and medicine.

   • Target 5.c: Adopt and strengthen sound policies and enforceable legislation for the promotion of gender equality.

     The article explicitly mentions policy-level actions, such as the “2016 federal law” that created the “Task Force on Research Specific to Pregnant Women and Lactating Women.” The task force’s recommendations for “future guidance” and new regulations are direct examples of strengthening policies to ensure the health needs of women are equally addressed.

3. SDG 10: Reduced Inequalities

   • Target 10.3: Ensure equal opportunity and reduce inequalities of outcome, including by eliminating discriminatory laws, policies and practices.

     The recommendation to “declassify pregnant women as a ‘vulnerable population’ in research regulations” is a clear effort to eliminate a policy that has led to unequal outcomes in health research and care. By changing this classification, the goal is to provide equal opportunity for pregnant women to participate in and benefit from clinical trials.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

• Indicator for Target 3.8: The proportion of essential medicines with established safety and efficacy data for use during pregnancy.

  The article implies this indicator by repeatedly mentioning the “gap in research” and the lack of “best information” to guide conversations about medication. Progress would be measured by an increase in the number of drugs that have been specifically tested and approved for use by pregnant and lactating women.

• Indicator for Target 5.1 and 10.3: The number of clinical trials that include pregnant and/or lactating women.

  The article’s focus on the “historical exclusion” of this population from trials suggests that a key measure of progress would be the rate of their inclusion in future research. An increase in the proportion of relevant drug trials that actively and ethically enroll pregnant participants would indicate a reduction in this discriminatory practice.

• Indicator for Target 5.c: The number of national policies or regulations updated to support and guide research involving pregnant women.

  The article mentions the 2016 federal law and the subsequent Task Force report with recommendations. An indicator of progress would be the formal adoption and implementation of these recommendations, such as declassifying pregnant women as a “vulnerable population” and developing programs that “prioritize the development of treatments specifically for pregnant and lactating people.”

4. Summary Table of SDGs, Targets, and Indicators

Source: whyy.org