Overview

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.

Full Product Details

Author:   Kristine E. Shields (Women’s Health Clinician, Researcher, and Advisor, Shields’ Medical Writing and Consulting)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Weight:   0.410kg
ISBN:  

9780128185506

ISBN 10:   0128185503
Pages:   244
Publication Date:   24 May 2019
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand  
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Table of Contents

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 Appendices 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

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Author Information

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.

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