Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report

Background:Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability tocontribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significantroom for improving the clarity, efficiency, and implementation of the assent process. Beyond ethical necessity of informingchildren about their treatment, the assent process provides the advantages of including children in discussions about theirdiagnosis and treatment—allowing greater understanding of interventions included in the study. A formalized assent processacknowledges the child as a volunteer and provides a forum for questions and feedback. Legal, cultural, and social differences havehistorically prevented the development of clear, concise, and accessible materials to ensure children understand the clinical trialdesign. Published guidelines on obtaining pediatric assent are vague, with many decisions left to local institutional review boardsand ethics committees, underscoring the need for collaboratively designed standards. To address this need, 2 surveys wereconducted to quantify perspectives on assent in pediatric clinical trials.Methods:Two digital surveys were circulated in the UnitedStates and internationally (October 2014 to January 2015). The first survey targeted children, parents, and/or caregivers. Thesecond polled clinical trial professionals on their organizations’ experience and policies regarding pediatric assent.Results:Forty-five respondents completed the child and parent/caregiver survey; 57 respondents completed the industry survey. Respondentsfrom both surveys detailed experiences with clinical trials and the impediments to securing assent, offering potential solutions toattaining assent in pediatric patients.Conclusions:An important opportunity exists for standardized practices and tools to ensurepediatric patients make well-informed decisions regarding their participation in clinical trials, using materials appropriate to theirlevel of understanding. These tools would establish a baseline standard for the assent process and be made available toresearchers, improving their ability to secure assent from young patients