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Pregnant Women Clinical Trials: Scientific, Regulatory, and Ethical Considerations Karen Feibus, MD, Medical Team Leader Pediatric and Maternal Health Staff (PMHS), Maternal Health Team, Office of New Drugs CDER/FDA Sara F. Goldkind, MD, MA, Senior Bioethicist Office of Good Clinical Practice, OC/FDA Objectives Explore ethical considerations for drug development research in pregnant women Examine different ways to obtain data in pregnant women during various stages of the drug development process Premarketing vs. postmarketing Clinical trials vs. epidemiological studies Obtaining pharmacokinetics data Enrolling pregnant women vs. continuation of women who become pregnant in a clinical trial Study design considerations Informed consent Outcomes measures Pharmacokinetics Basic Principles: an ethical and scientific foundation Agree with the following principles*: “Women need effective treatment during pregnancy” “Fetal safety”: Data are needed on fetal safety Inadequately treated mother compromises fetal well being “Reticence to prescribe needed medications: the cost of uncertainty” What are the risks of not treating or under treating the mother’s condition? “Issues of justice and access to the benefits of research participation” *Lyerly AD, Little MO, Faden R. The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth 2008 Fall; 1(2): 5-22. Basic Principles: an ethical and scientific foundation The most compelling reason to include pregnant women in a greater number of biomedical studies is to gather evidence under rigorous scientific conditions Fewer women and their fetuses are placed at risk compared to the much larger number of pregnant women who will be exposed to the medications once they come to market.* The next logical-and ethical-step is the enrollment and retention of pregnant women in clinical trials.* Safety signals can be more readily interpreted when detected in a clinical s