Improving Pediatric Clinical Trials by Incorporating Parent Input
Improving Pediatric Clinical Trials by Incorporating Parent Input https://pediatricsnationwide.org/wp-content/uploads/2025/01/84008631-1024x681.jpg 1024 681 Katie Brind'Amour, PhD, MS, CHES Katie Brind'Amour, PhD, MS, CHES https://pediatricsnationwide.org/wp-content/uploads/2021/03/Katie-B-portrait.gif- February 04, 2025
- Katie Brind'Amour, PhD, MS, CHES

A Parent Council in an ongoing pediatric stroke rehabilitation trial provides important insights into how parent involvement can inform and enrich the research process.
While the need for diverse and inclusive clinical trial populations has been acknowledged for the last few decades, the value of input into trial design from the patient (and in pediatrics, the parent) community has only emerged fairly recently. Understanding what makes a study more manageable for participants can be valuable for recruitment and retention. Furthermore, including outcome measures that reflect the treatment goals of patients can help ensure that emerging therapies address high-priority needs.
One example of structured parental feedback mechanisms for trial design and implementation, now described in Pediatrics, is the Parent Council in an ongoing Phase 3 clinical trial for pediatric post-stroke rehabilitation, the I-ACQUIRE study, which formally incorporated parent input since initial study funding in 2019.
The I-ACQUIRE research team planned for parental involvement early on, including it in the grant submission for the trial. The effort was a natural extension of an existing parental advisory relationship between initial Parent Council co-chairs and I-ACQUIRE Principal Investigator Sharon Landesman Ramey, PhD, research professor and distinguished research scholar at the Fralin Biomedical Research Institute at Virginia Tech, who had long appreciated parental insights into her own research planning for children with cerebral palsy and stroke.
“Studies that involve parent input may be more expensive to operate, but there is an important downstream benefit,” says Warren Lo, MD, attending pediatric neurologist in the Stroke and Vascular Anomalies Clinic at Nationwide Children’s Hospital and the other principal investigator of the I-ACQUIRE study.
In Dr. Lo’s view, incorporation of family input into study design and execution can help make participation in studies more accessible, understandable and predictable for potential participants.
“It helps researchers better understand the family’s perspective in how to reach out about participation in studies, and to learn both the positive and negative experiences parents had in other studies or treatment,” says Dr. Lo. “For potential participants, it is very important to get a family’s insights into what it’s like to take part in the trial.”
Parent Council work in I-ACQUIRE resulted in parent-friendly plain-language materials, “warm welcome” communications, site-specific tips on where to stay and how to manage family needs during the trial, as well as broader recruitment efforts via social media and direct outreach to advocacy groups. Parents on the Council could share with others their own experience with a similar high-intensity treatment regimen (constraint-induced movement therapy [CIMT]) as well as their approach to managing other responsibilities during treatment.
The study met its recruitment goal of 216 patients across 15 sites — despite the Covid-19 pandemic just after launch. They expect final results in the fall of 2025.
“Family and patient councils should have a voice that gets integrated with the larger clinical research process, not as a dominant or subservient group but as a key partner,” says Dr. Lo, who also plans to invite parents to provide input on an upcoming study he has planned involving remote CIMT. “The real magic is in striking an appropriate balance of getting that input and using it appropriately.”
For I-ACQUIRE, the Parent Council and study staff met regularly to share updates and gather input from each other. While the Council experienced some turnover throughout the 6 years of the study, several parents involved are part of the original group and have become active advocates in the pediatric neurology community, even attending international meetings, presenting on the experience at conferences, and publishing details about the Council’s structure, management and contributions in the Pediatrics article.
“We didn’t want to create a council and then have them sit on the shelf, with no impact on the study,” says Dr. Lo, who believes funding agencies should promote and support the effort to involve parent or patient advisors in research. “It was important for the study team to actively engage the Parent Council throughout the duration of the study, and our needs for the input of the council evolved over time.”
Reference:
Yale MM, Birch TB, Murray J, Dodds N, Hindery K, Darragh A, Ramey SL, Lo WD; I-ACQUIRE Parent Council. Parent Council for a Pediatric Stroke Rehabilitation Clinical Trial. Pediatrics. 2024 Oct 1;154(4):e2023064477.
About the author
Katherine (Katie) Brind’Amour is a freelance medical and health science writer based in Pennsylvania. She has written about nearly every therapeutic area for patients, doctors and the general public. Dr. Brind’Amour specializes in health literacy and patient education. She completed her BS and MS degrees in Biology at Arizona State University and her PhD in Health Services Management and Policy at The Ohio State University. She is a Certified Health Education Specialist and is interested in health promotion via health programs and the communication of medical information.
- Katie Brind'Amour, PhD, MS, CHEShttps://pediatricsnationwide.org/author/katie-brindamour-phd-ms-ches/April 27, 2014
- Katie Brind'Amour, PhD, MS, CHEShttps://pediatricsnationwide.org/author/katie-brindamour-phd-ms-ches/April 27, 2014
- Katie Brind'Amour, PhD, MS, CHEShttps://pediatricsnationwide.org/author/katie-brindamour-phd-ms-ches/April 27, 2014
- Katie Brind'Amour, PhD, MS, CHEShttps://pediatricsnationwide.org/author/katie-brindamour-phd-ms-ches/April 28, 2014
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