Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm

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 adolescentsDiscusses historical roots of separate drug approval in officially labeled children and the conflicts of interest in performing and publishing pediatric researchHelps to decipher justifications for pediatric studies and thus can help people to navigate the relevance of the information INDICE: 1. Introduction 2. Background 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

• ISBN: 978-0-12-823888-2
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 240
• Fecha Publicación: 27/11/2020
• Nº Volúmenes: 1
• Idioma: Inglés