Inclusion of Pregnant and Lactating Persons in Clinical Trials Proceedings of a Workshop (2023) / Chapter Skim
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4 Lessons Learned
4 Lessons Learned
Pages 43-56
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From page 43... ...
• Training is needed to better enable researchers to navigate the regulations and review processes associated with including pregnant persons in clinical studies of conditions that are not pregnancy specific. (Swamy)
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From page 44... ...
guidance had been released in 2019 and included 22 recommendations promoting the equitable inclusion of the interests of pregnant persons in the development and delivery of vaccines for emerging epidemics.1 As well, the value of maternal immunization was acknowledged based on a long history (e.g., maternal influenza immunization during the 2009 H1N1 pandemic) , and many obstacles to vaccinating pregnant persons had been addressed.
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From page 45... ...
She said that, during Operation Warp Speed, "special populations" were essentially set aside for later, even though it was becoming clear that pregnant people were at greater risk for serious disease than children were. She added that there was no biological reason to exclude lactating people from clinical trials and from receiving the vaccines.
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From page 46... ...
Wisner, the Norman and Helen Asher professor of psychiatry and obstetrics and gynecology, and director of the Asher Center for the Study and Treatment of Depressive Disorders at Northwestern University. Perinatal mood disorders are common in pregnant persons, and a study by Wisner found that 14 percent (1 in 7)
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From page 47... ...
Wisner has funding from the National Institute of Child Health and Human Development to study repurposing mirtazapine to treat severe nausea and vomiting in pregnancy, and she described the types of comments she received from the study section review. One comment centered on why mirtazapine would be used over ondansetron (another antiemetic)
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From page 48... ...
. In an effort to understand the activity of CYP3A4 in pregnancy, Wisner and her colleague sought out to conduct a probe study at the end of the first, second, and third trimesters and postpartum in healthy pregnant persons.
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From page 49... ...
She suggested creating a training pipeline to build the expertise needed to navigate the regulations and review processes associated with including pregnant persons in clinical studies of conditions that are not pregnancy specific. As an example, she noted that clinical trials funded by the National Institutes of Health of a vaccine for pandemic H1N1 influenza were halted three times over a 4-week period owing to preterm births because the investigators were primarily adult infectious disease physicians who assumed that outcomes had to be vaccine associated.
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From page 50... ...
Pfizer's data monitoring committee for the RSV trial included experts in obstetrics, maternal health, pediatrics, and pulmonary medicine. Conducting clinical trials with pregnant p ersons 5 After the workshop, Pfizer released interim data that showed the vaccine was effective in preventing severe illness due to RSV in infants, and expected to submit a regulatory appliction by the end of 2022.
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From page 51... ...
Another lesson from the COVID-19 vaccine trials that Pfizer is also applying, Munjal said, is the need to keep trial participants informed of any changes to the ongoing study. Munjal also discussed the challenges of recruiting for clinical trials of products that are already approved for adult populations and available to pregnant and lactating persons.
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From page 52... ...
For the IRB review process, she noted that the length of review is often extended by rounds of challenges and comments from the IRB related to the inclusion of pregnant persons that the sponsor must address (as demonstrated in Wisner's case example)
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From page 53... ...
She suggested that the broader community needs to be engaged in identifying research priorities, and that new models are needed to make development and reproductive toxicology testing more efficient and to reduce the number of animals needed for testing. Yao suggested focusing on identifying the specific data needed during pregnancy, rather than on specific studies to be done in pregnant persons, and presenting a plan to collect that data for discussion with regulators.
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From page 54... ...
In contrast, Munjal said that trial startup timelines outside of the United States were a barrier to conducting placebo controlled COVID-19 vaccine trials in many countries. The lesson learned was the need to have the infrastructure already in place to be able to activate trial sites.
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From page 55... ...
Sabra Anckner, Association of Maternal and Child Health Programs, emphasized the importance of obtaining the patient's informed consent to use their data for research purposes. "Just because we have data does not mean that it's ours to use and share," she said.
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