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Pregnancy and the Pharmaceutical Industry

The Movement towards Evidence-Based Pharmacotherapy for Pregnant Women

  • 1st Edition - May 24, 2019
  • Latest edition
  • Author: Kristine E. Shields
  • Language: English

Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials wi… Read more

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Description

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.

Key features

  • 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

Readership

Anyone involved in clinical trials including pharmaceutical company researchers and executives, research physicians and nurses, personal injury lawyers, medical ethicists

Table of contents

Part I. The Background, the Debate, and the Ethics Involved1. Drug Testing and Pregnant Women: Background and Significance2. The Rationales for and Against Inclusion3. The Ethics Involved

Part II. Quantitative and Qualitative Discoveries4. A Measure of Exclusion5. Perspectives from the Industry: On Exclusion6. Perspectives from the Industry: On Inclusion7. Perspectives from the Industry: On Litigation, Regulation, Incentives, and Indemnity8. Perspectives from the Industry: On Ethics

Part III. Uniting the Regulators, the Industry, and the Advocates9. The FDA Guidance, Public Comment, and Affinity with Stakeholders10. Proposed Actions for FDA and the Pharmaceutical Industry11. A Chance at Change12. After the Guidance

AppendicesFDA Guidance Document - Pregnant Women: Scientific and Ethical Consideration for Inclusion in Clinical TrialsTaskforce on Research Specific to Pregnant Women and Lactating Women: Report to the Secretary, Health and Human Services. Executive Summary

Product details

  • Edition: 1
  • Latest edition
  • Published: May 24, 2019
  • Language: English

About the author

KS

Kristine E. Shields

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.
Affiliations and expertise
Women’s Health Clinician, Researcher, and Advisor, Shields’ Medical Writing and Consulting

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