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Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities.
Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource.
- Explores the medical, ethical, scientific and legal rationales behind the inclusion of pregnant women in drug studies
- Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing
- Shares views from pharmaceutical industry insiders about company risks, reluctance to implement guidance, and the ultimate need to include pregnant women in studies
Anyone involved in clinical trials including pharmaceutical company researchers and executives, research physicians and nurses, personal injury lawyers, medical ethicists
Part I. The Background, the Debate, and the Ethics Involved
1. Drug Testing and Pregnant Women: Background and Significance
2. The Rationales for and Against Inclusion
3. The Ethics Involved
Part II. Quantitative and Qualitative Discoveries
4. A Measure of Exclusion
5. Perspectives from the Industry: On Exclusion
6. Perspectives from the Industry: On Inclusion
7. Perspectives from the Industry: On Litigation, Regulation, Incentives, and Indemnity
8. Perspectives from the Industry: On Ethics
Part III. Uniting the Regulators, the Industry, and the Advocates
9. The FDA Guidance, Public Comment, and Affinity with Stakeholders
10. Proposed Actions for FDA and the Pharmaceutical Industry
11. A Chance at Change
12. After the Guidance
FDA Guidance Document - Pregnant Women: Scientific and Ethical Consideration for Inclusion in Clinical Trials
Taskforce on Research Specific to Pregnant Women and Lactating Women: Report to the Secretary, Health and Human Services. Executive Summary
- No. of pages:
- © Academic Press 2019
- 24th May 2019
- Academic Press
- Paperback ISBN:
- eBook ISBN:
Dr. Shields is an OB/GYN nurse practitioner with a doctoral degree in Public Health. As a clinician she provided inpatient and ambulatory care in obstetrics and gynecology. As an epidemiologist she was responsible for the development and operation of the Pregnancy Registry Program at Merck, one of the earliest and most comprehensive pregnancy registry programs within the pharmaceutical industry. As a researcher/writer, she has published scientific papers in Obstetrics & Gynecology, Pediatrics, Birth Defects Research and other medical journals. Dr. Shields is most widely known for her research into medication safety during pregnancy.
Women’s Health Clinician, Researcher, and Advisor, Shields’ Medical Writing and Consulting