Clinical Research in Paediatric Psychopharmacology

A Practical Overview of the Ethical, Scientific, and Regulatory Aspects

Inbunden, Engelska, 2019

Av Philippe Auby, France) Auby, Philippe (CEO and President, Otsuka Pharmaceutical Development and Commercialisation Europe

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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.

Covers both theoretical and practical aspects of clinical research in paediatric psychopharmacology
Approaches the topic from different angles from the regulatory framework to the patient perspective
Discusses ethical and safety considerations for research in paediatric psychopharmacology
Offers future perspective for paediatric development

Produktinformation

Utgivningsdatum2019-09-17
Mått152 x 229 x 11 mm
Vikt470 g
FormatInbunden
SpråkEngelska
SerieWoodhead Publishing Series in Biomedicine
Antal sidor218
FörlagElsevier Science
ISBN9780081006160

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Farmakologi inom Medicin

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.

1. Introduction2. Historical perspective3. Worldwide paediatric regulations4. Are the paediatric rewards adapted?5. Child and adolescent psychopharmacology at the beginning of the 21st century6. Ethical aspects of research in paediatric psychopharmacology7. Study design and methodology8. Special challenges in paediatric recruitment9. The issue of indiscriminative efficacy trials and placebo effects in paediatric psychopharmacology10. Running clinical trials in paediatric psychopharmacology11. Listening to the patients’ voice12. Specificities of safety management in paediatric psychopharmacological research13. Why do we need to publish paediatric data?