Pediatric clinical trials: a US perspective

Matthew J Oelstrom,1 Margo L Hoover-Regan2 1Children’s Hospital of Wisconsin, Milwaukee, WI, USA; 2Division of Pediatric Hematology and Oncology, The University of Wisconsin School of Medicine and Public Health, Madison, WI, USA Background: Since the scientific revolution, systematic child-subject experimentation has evolved, with regard not only to scientific methodology but also to appreciation of the vulnerability of pediatric subjects. Permission-assent or informed consent policies serve to protect pediatric subjects. Unfortunately, child-subject and parent-surrogate understanding of research is not satisfactory. Methods: The PubMed, Essential Evidence Plus, and CINAHL Plus databases were searched for literature on informed consent, permission, and assent in pediatric clinical trials. Articles with an emphasis on the parents' and subjects' understanding of clinical trials were selected for review and summary. Results: Seventy unique articles satisfied the search criteria. Each article was reviewed thoroughly for information about the informed consent process, parent (and, in some cases, child-subject) understanding of the nature of specific pediatric clinical trials, and procedures used or proposed to improve understanding of clinical research by subjects and/or their parents. Conclusion: Many parent-surrogates and child-subjects do not adequately understand clinical research. Parents and children often fail to understand randomization, especially as it relates to the principle of clinical equipoise. Children have additional difficulty with the nature of placebos and with right to withdraw from research at any time. Future research should prospectively evaluate interventions such as "staged consent," public education, medical trainee education, and alternative information-delivery methods, which are not yet known to consistently affect understanding. Keywords: informed consent, permission-assent, subject understandin