An updated American Academy of Pediatrics (AAP) guideline on the ethical conduct of pediatric clinical trials aims to provide comprehensive guidance in this growing area of clinical research. Another report probes the challenges of obtaining meaningful assent from children and adolescents.
The revised guideline, which replaces a one issued by the AAP in 1995, reflects growing support for clinical research in pediatric populations since that time (Shaddy RE and Denne SC. Pediatrics. 2010;125:850-860). It includes many of the same elements as the original guideline, such as the need for strong trial design and proper protections for research participants, said Scott C. Denne, MD, chair of the AAP committee on pediatric research, which worked on the revision with the academy's committee on drugs. But it also places a greater emphasis on having a robust data monitoring committee that can quickly end a trial if an unexpected safety problem is identified.
Kuehn BM. Reports Promote High Standards for Ethical Conduct of Pediatric Clinical Trials. JAMA. 2010;303(18):1800. doi:10.1001/jama.2010.579