Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects

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 researchThe role of families and patients: 'should I involve my kid in a clinical research?Historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology will be covered. Covers both theoretical and practical aspectsDevelops different angles from the regulatory frame to the patient perspectiveProposes insights rather than tipsOffers future perspective for paediatric development INDICE: 1. Introduction2. Historical perspective3. Regulatory changing environment - US - EU - rest of World & WHO4. Scientific - state of the art - child and adolescent psychopharmacology at the beginning of the 21st century5. Ethical aspects of research in paediatric psychopharmacology - including ethics committee interactions, consent and assent procedures6. 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 devlopment9. Future methodological perspectives - including simulation, modeling and extrapolation - innovation in child and adolescent psychiatry10. Future of child and adolescent psychopharmacological research11. Conclusion12. References

• ISBN: 978-0-08-100616-0
• Editorial: Woodhead Publishing
• Encuadernacion: Cartoné
• Páginas: 512
• Fecha Publicación: 01/11/2017
• Nº Volúmenes: 1
• Idioma: Inglés