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Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines the historical roots why the United States (US) and European Union (EU) regulatory authorities, pediatric academia, and pharmaceutical industry demand, support and perform pediatric drug studies; the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child"; why most pediatric regulatory studies lack medical sense and many even harm young patients; and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children, and adolescents. Considering the Patient in Pediatric Drug Development helps healthcare professionals – and parents – to differentiate reasonable from questionable studies in young patients and navigate through the interface of good existing healthcare and fundamental flaws of pediatric clinical research and pediatric drug approval.
Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs including key differences between newborns, infants, older children, and adolescents. Discusses historical roots of separate drug approval in officially labeled "children" and the conflicts of interest in performing and publishing "pediatric" research.
Helps to decipher justifications for pediatric studies and thus can help people to navigate the relevance of the information.
Pharmaceutical personnel, physicians, nurses, pharmacologists, regulatory authorities, other healthcare professionals and those involved in clinical trials. Parents, patients and patients advocacy groups
3. Is fraud involved in the "pediatric" studies triggered by regulatory authorities?
4. Strengths, myths and misunderstandings of clinical studies methodology
5. US pediatric legislation
6. Expansion of "pediatric drug development" by the European Union (EU)
7. Specific disease areas
8. Clinical studies registries, including www.clinicaltrials.gov
9. A checklist for individual "pediatric" studies
10. Which studies do young patients need?
11. Criticism of pharmaceutical industry and drug development
12. Conflicts of interest in "pediatric drug development"
13. The way forward
- No. of pages:
- © Academic Press 2021
- 27th November 2020
- Academic Press
- Paperback ISBN:
Klaus Rose studied psychology, Latin languages and medicine. He was Global Head Pediatrics of Novartis 2001 – 2005 and of Genentech/Roche 2005 – 2009 (both large international pharmaceutical companies) and is independent since 2011. He publishes in international peer-reviewed journals and has co-edited three textbooks on pediatric drug development.
klausrose Consulting, Pediatric Drug Development & More; Riehen (Basel), Switzerland
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