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Pregnancy 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...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Academic Press,
[2019]
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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