Like clinical trials in adult populations, pediatric clinical trials increasingly incorporate electronic patient-reported outcome (ePRO) systems to gather data directly from patients. One challenge unique to pediatric trials is that many trials also seek to gather information from one or more caregivers, known as informants. The chosen informant is often a parent, but depending on the individual child’s family situation, multiple people may fulfill this role—mothers and fathers in separate households, grandparents, or stepparents. In some instances, a patient and their parent may share a device. In others, the patient and each parent may have separate devices.
These varied situations mean that pediatric trials utilizing informants need maximum flexibility in an ePRO solution—all while maintaining the same level of data security, traceability, and regulatory compliance (FDA 21CFR Part 11 and GDPR). The ePRO solution should allow multiple informants to enter data across multiple devices and device types, each with a unique username and password. Ideally, informants should be able to access the system on mobile devices (Android and iOS) and online through a desktop computer.
Sponsors considering ePRO in pediatric trials may also want to consider a hybrid approach that allows for both bring-your-own-device (BYOD) and provisioned devices. Many parents and caregivers will prefer the convenience of accessing diaries and questionnaires from their phones. Some caregivers, including grandparents, may not have access to a smartphone and are more likely to participate if given a provisioned device. Additionally, provisioned devices can also be used to capture data from pediatric patients when they are not with a parent or caregiver whose device they usually use. If provisioned devices will not be used, it is vital to ensure that patients can access the system across multiple devices. This is particularly true in shared custody situations where routinely getting access to the same device may be prohibitive to participating in a trial.
Learn how Pathway can provide the features you need to support your next pediatric clinical trial.