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International Clinical Trials

Innovation in Paediatric Trials: Conducting Study Visits at Home

Patient participation in paediatric clinical trials involves the entire family, which presents unique challenges for both subjects and researchers. Logistical challenges on the family, such as transportation, childcare for other children, and balancing the substantial commitments of time and effort, often result in lengthy recruitment times and narrower patient populations for paediatric clinical trials. These same challenges also make evaluability, patient retention, and treatment compliance a struggle.

Fortunately, recent innovations in trial designs are addressing some of these barriers to recruitment and participation. Their new technologies and procedures help alleviate burdens for the subjects and their families without compromising the integrity of clinical trial procedures or the measurement of endpoints.

The Paediatric Patient Journey

To conceptualise the patient journey in the paediatric research space, imagine a parent of three children who agrees to have one child participate in a clinical trial. The challenges involved in simply getting to the clinic may mean excusing them from school, taking time off work, scheduling a babysitter for the other two children, or herding all three children into the car and finding ways to keep them entertained while at the clinic.

Families may also face additional challenges, such as changing or unstable housing, financial concerns, unreliable transportation, and changing phone numbers (1). These barriers and more can lead to poor treatment compliance or visit attendance during the course of the trial, or even to early withdrawal from the study

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Jamie Wardynski, MBA, is a Director of Clinical Operations atPaidion Research. Jamie has 10 years’ experience in operational delivery of clinical trials, including the recent implementation of a decentralised clinical trial in the paediatric research space.

Kumar Ilangovan, MD, is a board-certified paediatrician, and clinical informatics physician serving as Medical Monitor atPaidion Research. He has worked both clinically and on multiple public and health services research studies spanning 20 years.

Jordan Godwin is a member of the American Medical Writers Association and a consultant Medical Writer at Paidion Research, where she writes and edits regulatory documents for paediatric clinical trials.

Betsy Reid is Co-Founder and Chief Operating Officer of Paidion Research. Betsy has 25 years’ experience in executive management of operations within academic, pharma, and CRO industries.
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