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5 Potential Practical Solutions for Including Pregnant and Lactating Persons in Clinical Trials
Pages 57-64

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From page 57...
... • Create an end-to-end product development framework for pregnant and lactating persons, from preclinical models and platform approaches to safety data, to translation into prac tice and linked pregnancy surveillance, pharmacovigilance, 57
From page 58...
... For pregnant and lactating persons who might be aware, access to and understanding of information about a clinical trial and completing the informed consent process have been identified as barriers to recruitment and retention, Henderson said. Studies have found that having information delivered by someone the patient trusts and ensuring that patient priorities have been incorporated into the trial design can help to facilitate participation.
From page 59...
... A recent systematic review of pregnant patients' reasons for participating in clinical research included: • altruism (a desire to help others and/or contribute to science) ; • collateral benefits of participation such as services provided (e.g., vaccination, free ultrasound, enhanced care)
From page 60...
... , which is linked to clinical trials and clinical research.2 Standardized protocols and harmonized regulatory guidelines across companies, platforms, and countries could help facilitate regulatory approval and recommendation for use across regions. Regulatory incentives could encourage manufacturers to include pregnant and lactating persons in clinical trials.
From page 61...
... As an example, she mentioned that the Gates Foundation has long invested in global maternal health and awards grants to support clinical research in pregnancy. She also encouraged a global approach to the inclusion of pregnant and lactating persons in clinical trials because half of the pregnancies worldwide occur in low- and middle-income countries where access to medicines can be limited.
From page 62...
... When people have not had adequate counseling or preparation the reaction is to stop any medications without considering any available evidence or looking for a trial to enroll in. Henderson agreed that preconception care and planning are important but added that 54 percent of counties in the United States have inadequate access to maternal care, 35 percent of which are "maternity care deserts," leaving a significant proportion of reproductive-age women without access to maternity care providers or facilities in their county (March of Dimes, 2020)
From page 63...
... ; having clinical research staff travel to communities; using community-based partners to reach potential participants who do not ­routinely access prenatal care (e.g., not-for-profit social and health orga nizations that work with patients in low-resource settings) ; and using mobile technology to send study reminders, questionnaires, or other key study information.
From page 64...
... Bettendorf said that ­community-based efforts have been effective in promoting pregnancy related interventions such as infant nutrition and breastfeeding, and there is an opportunity to engage community health providers and community based organizations as partners in recruitment for clinical trials. These partners can help to develop culturally competent promotional materials and trial designs.


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