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Pediatric Clinical Research Pharmacist, Department of Pediatrics, MCHK-PE Tripler Army Medical Center, HI. The views expressed in this book review are those of the author and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the US Government.
Published Online, May 15, 2007. www.theannals.com, DOI 10.1345/aph.1K030
Format: The book contains 15 chapters and a subject index with biography sections on authors and editors. Although written in English at approximately the 12th grade reading level, the subject matter requires a basic understanding of clinical research principles.
Audience: The guide's intended audience is quite large and includes pediatricians, pharmacists, pharmacologists, and other healthcare professionals; regulatory affair and clinical trial personnel; pharmaceutical company managers; and lay persons. However, it is also an excellent primer reference for healthcare providers and students interested in learning more about the difficulties and nuances of conducting research in the pediatric population, both in the US and the European Union (EU).
Purpose: Written by experts in the fields of academia as well as representatives from the pharmaceutical industry, regulatory offices, and patient advocacy groups, the text explains the US and EU legislation as it pertains to pediatric drug research and use, gives an analysis of legislative impact, addresses key operational challenges in pediatric research, and develops a vision of future pediatric drug development. The book's goal is to familiarize the reader with current problems and proposed solutions to developing and researching drugs for approved use in children. It is a current, in-depth view of clinical research in children in the US and EU. The book could be used in healthcare degree programs that require a research component to their curriculum.
Content: The organization of material is appropriate and the topics are inclusive of information needed for an overview of pediatric clinical research in the US and EU. Extensive background information on the editors and authors for each chapter is included. The book chapters include "Europe's Path Towards Better Medicines for Children," "The European Academy of Paediatrics and Its Demand for More Clinical Research," "Paediatric Medicines: a View from Patient Organizations," "Paediatric Drug Development—Historical Background of Regulatory Initiatives," "International Conference on Harmonization (ICH): Clinical Investigation of Medicinal Products in the Paediatric Populations," "Ethical Challenges of Clinical Research in Children," "Consent and Assent in Paediatric Clinical Trials," "Collecting Blood and Tissue Samples in Paediatric Clinical Trials," "Paediatric Formulations," "Central Laboratory in Paediatric Clinical Trials," "Study and Protocol Design for Paediatric Patients of Different Ages," "Innovative Methodologies for Drug Evaluation in Children," "Challenges in Research of Very Small Children," "Clinical Research for Infant Nutrition," and "Conclusions: Paediatric Drug Development in a Global Context."
Usability: Contributions of multiple authors with different fields of expertise produced a current, up-to-date reference on the practical, ethical, and regulatory hurdles facing clinical researchers in the field of pediatrics. The authors and editors look toward the future, proposing solutions to problems in this difficult field of study rather than getting lost in the problems of the past. The text is reasonably priced and is a useful tool for those interested in gaining a solid knowledge base of international pediatric clinical research.
Highlights: This book is unique in that it includes both the US and EU perspective on conducting research in the pediatric population. The different countries' goals and study designs are very similar. Of special interest is the inclusion of a table on the regulatory differences between 20 countries on legal age to consent, number of parents/guardians needed for consent, and the youngest age for child assent.
Limitations: The mingling of regulatory issues from different countries is sometimes confusing; however, the research and ethical goals of the US and EU countries remain very similar.
Comparison with Other Related Books or Products: To my knowledge, this book is the first to present an international collaborative and collective view on this topic. It is up to date, and the US information presented is consistent with national standards and regulations. It could be used in both pediatric and research courses in the university setting.
Reviewer's Summary: Written and organized well and containing in-depth information on each topic presented, Guide to Paediatric Clinical Research is an excellent resource for researchers, regulatory personnel, patient advocacy groups, and investigational review board members. I would recommend it as an excellent reference for hospital medical libraries. It may also be useful to pharmacists, pharmacy students, and other healthcare professionals interested in pursuing a career or conducting clinical research in children.
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