Pregnancy and the Pharmaceutical Industry: The Movement Towards Evidence-Based Pharmacotherapy for Pregnant Women

Pregnancy and the Pharmaceutical Industry: The Movement Toward 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 when they are used during pregnancy, and it is impossible to extrapolate that information from drug studies on men and nonpregnant women. A majority of pregnant women confront a medical condition during their pregnancy, from simple pain to on-going or new medical issues to life-threatening emergencies. New draft guidance from the FDA offers specific recommendations to include pregnant women in drug studies that minimize risk and maximize therapeutic data. This book quantifies the current absence of pregnant women in drug studies and identifies the ethical issues, barriers, and litigation fears, but also the opportunities articulated by physicians, lawyers, ethicists, and other stakeholders in and around the pharmaceutical industry. Pregnancy and the Pharmaceutical Industry: The Movement Toward Evidence-based Care for Pregnant Women explores the views of the pharmaceutical industry on the inclusion of pregnant women in clinical studies, as well as presents information for stakeholders on the ethical rationale, context, and details to adapt to this new FDA guidance. Those in the pharmaceutical industry, IRB members, who approve or deny the drug study plan, 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 studiesDescribes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testingShares views from pharmaceutical industry insiders about company risks, reluctance to implement the guidance, but the ultimate need to include pregnant women in studies INDICE: 1. Testing Pregnant Women: Background and Significance 2  The Rationales For and Against Inclusion 3  Research on Pregnant women: An Ethical Framework 4. A Measure of Exclusion 5. Perspectives from the Industry 6. A Chance at Change 7. Discussion 8. New FDA Guidance on Pregnant Women in Research Studies Bibliography Appendix I. White Paper II. Answers to Key Informant Interview Questions III. FDA Guidance Document - Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials

• ISBN: 978-0-12-818550-6
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 320
• Fecha Publicación: 03/06/2019
• Nº Volúmenes: 1
• Idioma: Inglés