Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects will be developed and organised with the aim to be a practical guide first providing an overview of ethical, scientific and regulatory aspects of clinical research in paediatric psychopharmacology, and second discussing practical points to consider when developing clinical research in this field.
The targeted audience should be rather broad targeting professionals involved in clinical research in paediatric psychopharmacology i.e. including but not limited to paediatricians, health care professionals, researchers, investigators, pharmaceutical company personals, and potentially ethics committee members.
Other audience could be targeted by two specific chapters:
- The role of patient’s organization and advocacy groups in research
- The role of families and patients: ‘should I involve my kid in a clinical research?
- 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 paediatric development
Professionals involved in clinical research and healthcare professionals
2. Historical perspective
3. Regulatory changing environment – US – EU – rest of World & WHO
4. Scientific – state of the art – child and adolescent psychopharmacology at the beginning of the 21st century
5. Ethical aspects of research in paediatric psychopharmacology – including ethics committee interactions, consent and assent procedures
6. Clinical development – practical considerations – writing protocols – running clinical trials – specific paediatric formulation - proactive patient recruitment strategies… (the largest chapter)
7. Patients and family perspective – if it was my child?
8. Intercultural aspects – risks of clinical trial colonialism – global paediatric devlopment
9. Future methodological perspectives – including simulation, modeling and extrapolation – innovation in child and adolescent psychiatry
10. Future of child and adolescent psychopharmacological research
- No. of pages:
- © Woodhead Publishing 2018
- 1st June 2018
- 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 & Paediatrics, France