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.
1. 1: Introduction - p. xi 2. 2: Historical perspective - p. 3 3. 3: Worldwide paediatric regulations - p. 13 4. 4: Are the paediatric rewards adapted? - p. 38 5. 5: Child and adolescent psychopharmacology at the beginning of the 21st century - p. 65 6. 6: Ethical aspects of research in paediatric psychopharmacology - p. 80 7. 7: Study design and methodology - p. 98 8. 8: Special challenges in paediatric recruitment - p. 112 9. 9: The issue of indiscriminative efficacy trials and placebo effects in paediatric psychopharmacology - p. 120 10. 10: Running clinical trials in paediatric psychopharmacology - p. 151 11. 11: Listening to the patients’ voice - p. 172 12. 12: Specificities of safety management in paediatric psychopharmacological research - p. 182 13. 13: Why do we need to publish paediatric data? - p. 190 14. Conclusion - p. 201 15. Index - p. 203
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.
1. 1: Introduction - p. xi 2. 2: Historical perspective - p. 3 3. 3: Worldwide paediatric regulations - p. 13 4. 4: Are the paediatric rewards adapted? - p. 38 5. 5: Child and adolescent psychopharmacology at the beginning of the 21st century - p. 65 6. 6: Ethical aspects of research in paediatric psychopharmacology - p. 80 7. 7: Study design and methodology - p. 98 8. 8: Special challenges in paediatric recruitment - p. 112 9. 9: The issue of indiscriminative efficacy trials and placebo effects in paediatric psychopharmacology - p. 120 10. 10: Running clinical trials in paediatric psychopharmacology - p. 151 11. 11: Listening to the patients’ voice - p. 172 12. 12: Specificities of safety management in paediatric psychopharmacological research - p. 182 13. 13: Why do we need to publish paediatric data? - p. 190 14. Conclusion - p. 201 15. Index - p. 203
