Guide to Paediatric Clinical Research

Front Cover
Klaus Rose, John N. Van den Anker
Karger Medical and Scientific Publishers, 2007 - Medical - 137 pages
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.
 

Contents

Europes Path towards Better Medicines for Children
1
The European Academy of Paediatrics EAP CESP and Its Demand for More Clinical Research
5
A View from Patient Organisations
13
Paediatric Drug Development Historical Background of Regulatory Initiatives
25
Clinical Investigation of Medicinal Products in the Paediatric Population The International Guidance on Clinical Drug Development in Children
33
Ethical Challenges of Clinical Research in Children
38
Consent and Assent in Paediatric Clinical Trials
47
Collecting Blood and Tissue Samples in Paediatric Clinical Trials
59
Central Laboratory in Paediatric Clinical Trials
78
Study and Protocol Design for Paediatric Patients of Different Ages
87
Innovative Methodologies for Drug Evaluation in Children
108
Challenges in the Research of Very Small Children
115
Clinical Research for Infant Nutrition
126
Paediatric Drug Development in a Global Context
133
Author Index
135
Subject Index
136

Paediatric Formulations
65

Common terms and phrases

Bibliographic information