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

Clinical Research in Paediatric Psychopharmacology provides a comprehensive guide to the ethical, scientific, and regulatory aspects of clinical research in pediatric psychopharmacology, discussing practical considerations for professionals involved in this field.

\n Format: Hardback
\n Length: 218 pages
\n Publication date: 17 September 2019
\n Publisher: Elsevier Science & Technology
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Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific, and Regulatory Aspects is a comprehensive guide that provides a thorough exploration of the ethical, scientific, and regulatory dimensions of clinical research in pediatric psychopharmacology. It offers practical insights and considerations for professionals engaged in this field, including pediatricians, healthcare professionals, researchers, investigators, pharmaceutical company personnel, and potentially ethics committee members. The book delves into various topics, such as the role of patient organizations and advocacy groups in research, the involvement of families and patients in clinical research, and the historical, ethical, regulatory, clinical, scientific, intercultural, and practical aspects of clinical research in child and adolescent psychopharmacology.

Ethical considerations in pediatric psychopharmacology research are of paramount importance, as the potential benefits and risks of interventions must be carefully weighed. The book emphasizes the need for rigorous ethical review and approval processes, including obtaining informed consent from participants and their families. It also discusses the importance of protecting the privacy and confidentiality of research participants and ensuring the safety of both participants and researchers.

Scientific rigor is essential in clinical research, particularly in the field of psychopharmacology. The book provides an in-depth review of the scientific principles and methodologies used in pediatric psychopharmacology research, including study design, sample size calculation, statistical analysis, and interpretation of results. It also highlights the importance of conducting randomized controlled trials to establish the efficacy and safety of interventions.

Regulatory considerations are crucial in ensuring the ethical and safe conduct of clinical research. The book discusses the various regulatory frameworks and guidelines that apply to pediatric psychopharmacology research, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It provides guidance on the submission of research protocols, the conduct of clinical trials, and the reporting of research results.

In addition to the ethical, scientific, and regulatory aspects, the book also addresses practical points to consider when developing clinical research in pediatric psychopharmacology. It discusses the importance of collaboration between researchers, healthcare professionals, and patient organizations, as well as the need for effective communication and dissemination of research findings.

Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific, and Regulatory Aspects is an invaluable resource for professionals involved in clinical research in pediatric psychopharmacology. It provides a comprehensive and up-to-date understanding of the ethical, scientific, and regulatory considerations that underpin this field. By addressing these aspects, the book contributes to the advancement of knowledge and the improvement of patient care in pediatric psychopharmacology.

\n Weight: 470g\n
Dimension: 160 x 352 x 11 (mm)\n
ISBN-13: 9780081006160\n \n