Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects provides a practical guide and overview of the ethical, scientific and regulatory aspects of clinical research in pediatric psychopharmacology, also discussing practical points to consider when developing clinical research in this field. The book is ideal for professionals involved in clinical research in pediatric psychopharmacology, i.e., including, but not limited to pediatricians, health care professionals, researchers, investigators, pharmaceutical company personals and potentially ethics committee members.
Topics discussed include the role of patient organization and advocacy groups in research, the role of families and patients: 'should I involve my kid in clinical research, and historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology.
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1. Introduction 2. Historical perspective 3. Worldwide paediatric regulations 4. Are the paediatric rewards adapted? 5. Child and adolescent psychopharmacology at the beginning of the 21st century 6. Ethical aspects of research in paediatric psychopharmacology 7. Study design and methodology 8. Special challenges in paediatric recruitment 9. The issue of indiscriminative efficacy trials and placebo effects in paediatric psychopharmacology 10. Running clinical trials in paediatric psychopharmacology 11. Listening to the patients' voice 12. Specificities of safety management in paediatric psychopharmacological research 13. Why do we need to publish paediatric data?
Dr Philippe Auby is a Child and Adolescent Psychiatrist. He started his residency training in Psychiatry in 1986 and received his MD from the Toulouse University of Medicine, France. In 1989 and 1990, for his military service, the author worked as a psychiatrist in South East Refugee Camps in Thailand. After an initial training in adult psychiatry, he completed a board certification in child and adolescent psychiatry and a post-graduate diploma in psychology. His main research interests are in child and adolescent psychiatry, consultation/liaison psychiatry, and intercultural psychiatry. In 1996, he joined a CRO based in Paris before moving to Eli Lilly, then BMS in France and the European Headquarter in Belgium. Between 2004 and 2007, working for Otsuka America Pharmaceutical Inc., he developed global paediatric projects in psychopharmacology. Early 2007, he moved to Lundbeck to create the International Clinical Research Department of Paediatric Neuro-Psychiatry. In 2016, he went back to Otsuka and is now CEO and President of Otsuka Pharmaceutical Development and Commercialisation Europe.