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 a 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
- Develops different angles from the regulatory frame, to the patient perspective
- Proposes insights rather than tips
- Offers future perspective for pediatric development
Professionals involved in clinical research and healthcare professionals
2. Historical Perspective
3. Worldwide Paediatric Regulations
4. The basis of rewards in paediatric regulations
5. Child and Adolescent psychopharmacology at the beginning of the 21st century
6. Ethical and cultural 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
11. Listening to the Patients’ voice
12. Specificities of safety management in paediatric psychopharmacological research
13. Why it is important to publish paediatric studies?
- No. of pages:
- © Woodhead Publishing 2019
- 1st May 2019
- Woodhead Publishing
- Hardcover ISBN:
Dr Philippe Aubyis 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, schizophrenia, bipolar disorders, PTSD, consultation/liaison psychiatry and inter-cultural psychiatry. In 1996 he joined a CRO based in Paris before moving first to Eli Lilly France then to BMS France. In 2001, he moved to BMS European Headquarter in Belgium prior working for Otsuka America Pharmaceutical, in Princeton as Executive Director-CNS Abilify in 2004. Early 2007, he moved to Lundbeck to create the International Clinical Research Department of Paediatric Neuro-Psychiatry. His current title is Senior Medical Director, Corporate ICR France & Paediatrics.
Corporate ICR France and Paediatrics, France