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Inclusion of Pregnant and Lactating Persons in Clinical Trials Proceedings of a Workshop (2023) / Chapter Skim
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2 Effects of Evidence Gaps in Clinical Treatment for Pregnant and Lactating Persons
Pages 9-18

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From page 9...
... (Askin, Covin, Gorman, Mancoll) • Not treating a preexisting or pregnancy-related health con dition during pregnancy exposes the pregnant person and developing fetus to risk of adverse health outcomes.
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From page 10...
... Mancoll has a­ lopecia areata, a chronic autoimmune condition for which there is no cure and no particularly effective treatment.1 She described how, prior to becoming pregnant, she was able to keep her hair loss to a minimum through bimonthly corticosteroid injections. Although this process was painful and disruptive to her workday, it was relatively successful in limiting disease progression and spurring hair regrowth.
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From page 11...
... As a program manager at the Well Project, a nonprofit serving women living with HIV, Covin emphasized the need for clinical research to include parents with HIV who are pregnant or breastfeeding. Amber Griffith, a postdoctoral fellow at the Washington University School of Medicine in Saint Louis, was pregnant during the ongoing COVID-19 pandemic and said, "The vaccine and how it affects pregnant women was really important to me at that time." As a researcher, she emphasized that doctors need to have conversations with their patients to explain, "We're not just…pulling things out of thin air and…giving it to people.
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From page 12...
... Haas concluded that data are needed -- not only about the safety and efficacy of drugs used individually -- but also about the interactions of drugs when taken simultaneously during pregnancy. Haas stated that relatively little is known about the effects of drugs on pregnant individuals in the immediate postpartum period, when many physiological changes occur.
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From page 13...
... Ajoke Sobanjo-ter Meulen, vice president medical affairs and policy at Icosavax, pointed out that the lack of clinical evidence on the safety and efficacy of drugs in pregnant and lactating persons is part of a larger "gender data gap" issue that spans disciplines and sectors worldwide. Progress has been made by pioneering stakeholders and organizations, such as the development of a vaccine candidate for group B Streptococcus and several candidates for respiratory syncytial virus (RSV)
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From page 14...
... OUTCOMES OF EXCLUSION One of the outcomes of the exclusion of pregnant and lactating persons from COVID-19 vaccine clinical trials is that these populations lack confidence in these vaccines, said Zsakeba Henderson, senior vice president of maternal child health impact and the interim chief medical ­officer at March of Dimes. Although the Centers for Disease Control and Prevention (CDC)
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From page 15...
... at FDA and session moderator, said FDA often receives questions and comments about whether pregnant and lactating persons actually want to participate in clinical research. From her perspective as a patient, Mancoll said she believes she would have been open to the idea of enrolling in a clinical trial while pregnant, in part because she is personally a strong advocate for science.
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From page 16...
... . He said that, in his experience conducting clinical trials, there is wide variability in willingness to enroll in a trial among pregnant persons, and many pregnant individuals have a distrust of clinical research and may be hesitant to enroll in a trial.
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From page 17...
... Unfortunately, becoming pregnant is often one of the reasons listed in a protocol for a participant to be discontinued from a study, which, Sharon pointed out, is a missed opportunity to continue to learn from these patients. He noted that during the pivotal clinical trial for the Moderna COVID-19 vaccine there were 13 trial participants who became pregnant over the course of the study (FDA, 2020)
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Key Terms

  • clinical trials
  • clinical trial
  • pregnant persons
  • lactating individuals
  • lactating people

  • pregnant women
  • pregnant person
  • pregnant individuals
  • ensure patient
  • prevent severe

  • increased risk
  • patient safety
  • pharmacokinetic studies
  • severe disease
  • corticosteroid injections

  • clinical evidence
  • lactating women
  • conducting clinical
  • incentivize clinical
  • clinical study

  • lactating rodent
  • vaccine clinical
  • clinical studies
  • lactating person
  • include lactating

  • pivotal clinical
  • enrolling pregnant
  • ing pregnant
  • pregnant people
  • affects pregnant


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