Study of Practices for Obtaining Assent of Pediatric Patients in Clinical Trials Published

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The Institute for Pediatric Innovation (IPI) collaborated with biopharmaceutical companies Pfizer and Shire and healthcare communications firm The Medicine Group to conduct a study on practices for obtaining assent of pediatric patients who are asked to participate in clinical trials. The Journal of Therapeutic Innovation & Regulatory Science has just published the results.

The Institute for Pediatric Innovation (IPI) announces that the Journal of Therapeutic Innovation & Regulatory Science has just published the results of a study on practices for obtaining the assent of pediatric patients who are asked to participate in clinical trials.

This study, entitled “Industry and Patient Perspectives on Child Participation in Clinical Trials,” is a result of a collaboration among IPI, biopharmaceutical companies Pfizer and Shire and healthcare communications firm The Medicine Group. Coauthors on the study are Irmgard Eichler, Stephanie Gilstein, Donald Lombardi, Philip Sjostedt, Liza Squires, Charles Thompson and Mark Turner.

The issue of obtaining assent of pediatric patients has long been seen as a challenge in the medical world, especially since the introduction of new regulations in the early 2000s. Although children cannot generally provide legal informed consent until they reach adulthood, they need to be given age-appropriate information and asked to agree to participate in clinical trials.

The study focused on determining how varying stakeholders dealt with ambiguities inherent in the assent requirements and the differences observed among patients from a range of ages and populations, cultures, clinical trial types and regulatory environments.
Launched in 2014, the study centered around digital surveys offered both in the United States and internationally. The first survey polled children, parents and/or caregivers while the second was aimed at clinical trial professionals on their organizations’ experiences and policies regarding pediatric assent.

Forty-five respondents completed the child and parent/caregiver survey. Fifty-seven individuals completed the industry survey. Survey respondents offered their experiences of clinical trials and challenges they encountered to secure assent. Common obstacles included language barriers, cultural issues, disease severity and child maturity.

Respondents also surfaced potential solutions. Both children and parents/caregivers called for visual aids that would clearly explain the procedure while retaining a child’s attention. The study reports that standardized practices and tools would help pediatric patients make well-informed decisions about their participation in clinical trials. Such tools would establish a baseline standard for the assent process.

The results of the surveys indicate that a shift in handling management of child assent can provide relief for parents and children in a hospital setting.

If you are interested in reading the article, visit the online journal.

About IPI

The Institute for Pediatric Innovation (IPI) was founded as a nonprofit 501(c)3 corporation in 2006. The institute is managed and led by a consortium of pediatric hospitals, who, together with IPI staff, provide deep expertise in pediatric medical device and medicine innovation. IPI is managed and led by a consortium of pediatric hospitals from around the United States. Their expertise is joined by experts from all sectors to identify problem areas and create novel solutions and a worldwide network of collaborators to assist in translating innovations into commercially available solutions.

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Leanora Karnath

Donald Lombardi
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