Few children participate in clinical trials; parents often unaware

August 11, 2011

Less than 30% of FDA-approved medications have been studied in children, despite regulatory requirements and study incentives implemented by FDA over the past 15 years. One reason is parents' lack of awareness of opportunities for children to participate in medical research. Now, new tools can help pediatricians educate parents and increase children?s participation in clinical trials.

Less than 30% of US Food and Drug Administration (FDA)-approved medications have been studied in children, despite regulatory requirements and study incentives implemented by FDA over the past 15 years.

One reason is parents’ lack of awareness of opportunities for children to participate in medical research.

Although 68% of adults know about medical research opportunities for themselves, only 16% of parents know that such opportunities exist for their children. Just 5% of children have participated in any medical research program in the United States, according to a recent poll.

"To improve participation rates among children, researchers and institutions evidently need to do a better job of getting the word out to parents," said Matthew Davis, MD, director of the poll and associate professor in the Child Health Evaluation and Research Unit at the University of Michigan.

To help pediatricians explain to parents the importance of their children’s participation, the National Institutes of Health has created a Web site that explains pediatric medical research and how to enroll children in clinical trials. The site offers videos of children and their parents talking about the process, answers to common questions, and additional resources.

Those parents who are aware of opportunities to participate in medical research frequently express concern about the safety of their children in clinical trials. House Bill 2625, The Research Participants Protection Modernization Act of 2011, would provide additional protections to “vulnerable populations” used in medical research, including children. The bill was referred to the House Committee on Energy and Commerce in July.

Pediatricians who want to explore more opportunities for medical research for their patients may be interested in the work of the Pediatric Trials Network (PTN), which was created last year to increase the data on the efficacy, safety, and dosing of generic drugs in children. PTN has 5 studies in process and is currently recruiting participants in 2 clinical trials, according to a letter in the e-Journal of Neonatology Research. PTN plans to develop 6 new protocols in 2012 and to complete at least 14 pediatric clinical trials in the next 7 years.

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