Screen LibraryPregnancy and the pharmaceutical industry : the movement towards evidence-based pharmacotherapy for pregnant women /
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...
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| Main Authors: | |
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| Corporate Authors: | |
| Published: |
Academic Press,
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| Publisher Address: | London : |
| Publication Dates: |
[2019] ©2019 |
| Literature type: | eBook |
| Language: | English |
| Subjects: | |
| Online Access: |
https://www.sciencedirect.com/science/book/9780128185506 |
| Summary: |
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. |
| Carrier Form: | 1 online resource : illustrations |
| Bibliography: | Includes bibliographical references and index |
| ISBN: |
9780128190746 0128190744 9780128185506 0128185503 |
| Index Number: | RG528 |
| CLC: | R984 |
| Contents: |
Front Cover; Pregnancy and the Pharmaceutical Industry; Copyright Page; Dedication; Contents; List of figures; List of tables; Preface; Epigraph; List of abbreviations; I. The background, the debate, and the ethics involved; 1 Drug testing and pregnant women: background and significance; Background of the issue; Historical perspective; Proponents of inclusion; Significance of the issue; Ethical concerns; Aims of the book; Notes; 2 The rationales for and against inclusion; Rationales against the inclusion of pregnant women in clinical research Rationale 1: the uncertain effect of new drugs on the mother and/or the fetus6Ethical rationale: nonmaleficence; Rationale 2: litigation risk-because birth defects are not uncommon, they may occur unrelated to experimental drug exposure ... ; Ethical rationale: financial stewardship; Rationale 3: the number of pregnant women needed to participate in the study in order to show efficacy may be unachievable; Ethical rationale: nonmaleficence; Rationale 4: safer study designs are available; Ethical rationale: beneficence; Rationale 5: alternative treatments are often available Ethical rationale: beneficenceRationale 6: little return on investment; Ethical rationale: financial stewardship; Rationale 7: regulations do not require inclusion; Ethical rationale: financial stewardship; Rationales for the inclusion of pregnant women in clinical trials; Rationale 1: to acquire knowledge that improves the medical treatment of pregnant women and their offspring; Ethical rationale: beneficence, nonmaleficence; Rationale 2: to improve birth outcomes; Ethical rationale: beneficence, nonmaleficence Rationale 3: to improve pregnant women's access to the benefits of clinical researchEthical rationale: justice; Rationale 4: to improve the ethical acquisition of information about exposed pregnancies; Ethical rationale: nonmaleficence, autonomy; Rationale 5: regulations do not require the exclusion of pregnant women; Ethical rationale: justice; Rationale 6: excluding pregnant women from participating in medical research is unethical and illegal-and may increase liti ... ; Ethical rationale: justice; Rationale 7: to follow the advice of experts in the field of women's health, law, and ethics Ethical rationale: justice, nonmaleficenceNotes; 3 The ethics involved; Theoretical approaches; Principle-based ethics; The principle of respect for autonomy or respect for persons; The principles of nonmaleficence, beneficence, and the double effect; The principle of justice; Consequentialism; Feminist ethical theory; Business ethics; Special considerations for pregnancy/maternal-fetal ethics; Application of an ethical framework for studies with pregnant women; Notes; II. Quantitative and qualitative discoveries; 4 A measure of exclusion; The US clinical trial system |