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Challenges in Conducting Therapeutic Trials in Pregnancy: Emphasizing Recent Lessons Learned
Tracy Caroline Bank1, Catherine S Stika2, Raman Venkataramanan3
1Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Including pregnant individuals in clinical research is crucial for evidence-based care. Overcoming historical barriers and safety concerns requires a cultural shift to balance risks and benefits, respecting maternal autonomy.
Area of Science:
- Medical Ethics
- Clinical Research
- Maternal-Fetal Medicine
Background:
- Historically, pregnant individuals were excluded from therapeutic research due to fetal protection concerns.
- Despite progress, safety and feasibility issues continue to limit research involving pregnant populations.
- This exclusion hinders the development of evidence-based treatments for conditions affecting pregnant individuals.
Approach:
- Reviewed historical research guidelines and their impact on pregnant individuals.
- Examined challenges in including pregnant people in studies, using COVID-19 vaccines and preeclampsia statin trials as examples.
- Explored novel methodologies for enhancing therapeutic research in pregnancy.
Key Points:
- Past restrictions on pregnant individuals in research were intended for fetal protection.
- Ongoing challenges persist in including pregnant populations in clinical studies.
- New approaches are emerging to improve therapeutic research involving pregnant individuals.
Conclusions:
- A significant cultural shift is necessary to re-evaluate risk-benefit analyses in pregnant research participants.
- Respecting maternal autonomy in decision-making is paramount for ethical clinical trial participation.
- Ensuring evidence-based treatments requires overcoming barriers to research in pregnancy.
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