Considering the Patient in Pediatric Drug Development: A Critical Examination

In the realm of pediatric drug development, a crucial challenge has long been overlooked: the ambiguous use of the term “children” in clinical trials and practice. Despite its widespread adoption, this term fails to acknowledge the significant physiological differences between various age groups. Klaus Rose’s book delves into this critical issue, exploring how this ambiguity has led to harm rather than progress in healthcare for young patients.

The Flawed Approach to Pediatric Drug Studies

Regulatory authorities in the United States and European Union, as well as pediatric academia and the pharmaceutical industry, have been demanding, supporting, and performing pediatric drug studies. However, these efforts are often marred by significant flaws, including the blurring of administrative and physiological meanings of the term “child.”

In reality, pediatric drug studies often lack medical sense, and some even cause harm to young patients. This is further complicated by conflicts of interest that undermine the integrity of these studies.

Understanding the Maturation of the Human Body

To develop effective and safe pediatric drugs, it is essential to understand the absorption, distribution, metabolism, and excretion (ADME) of food and drugs in different age groups. The book provides valuable insights into the key differences between newborns, infants, older children, and adolescents, debunking the myth that “children” can be treated as a single, homogeneous group.

By exploring the historical roots of separate drug approval for officially labeled “children” and the conflicts of interest in performing and publishing pediatric research, this book aims to empower readers to navigate the complex landscape of pediatric drug development.

Klaus Rose’s book is a critical examination of the pediatric drug development process, offering a comprehensive understanding of the challenges and flaws that have hindered progress in this area. It is an essential read for anyone involved in pediatric healthcare, drug development, or research.

Book Details:
Publisher: Elsevier Science
Publication Date: November 19, 2020
Language: English
ISBN: 9780128238882, 9780128242056