Pediatric clinical trials

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Pediatric clinical trials

Conducting clinical trials with children comes with unique challenges that highlight the value of every piece of data we collect. Only 20% of the US population is younger than 14 years of age, meaning that the pediatric population is limited and making recruitment particularly challenging, especially since children are much less likely than adults to suffer from serious illnesses.

The pediatric patient population is also very diverse, with preferences and habits varying significantly across age ranges. Transitioning between age groups during the trial can cause confusion in the attribution of questionnaires, and both the disease and the clinical trial can conflict with important aspects of a child’s life.

“We need to consider the patient journey over time, as young patients may become teenagers or young adults by the end of the trial. Biological changes, consent requirements, and evolving expectations must be analyzed to keep patients engaged.“

Begoña Nafria, Head of the Patient Engagement in Research Department at SJD Research Foundation

To address these challenges, we collaborate closely with sites, as they are directly engaged with the patient population and have a thorough understanding of the specificities of pediatric clinical trials. This collaboration is crucial for the meaningful integration of electronic Clinical Outcome Assessments (eCOA) and to improve data collection and analysis.

Ensure the success of your pediatric clinical trial by partnering with an eCOA provider with solid knowledge of the specifics of pediatric research

Our medical and scientific department is highly involved, including:

Our skilled and experienced operational staff can:

Understand the challenges of the protocol, the patient population, the various age ranges, and the need for multiple accounts.
Anticipate the risks if patients move from one age category to another.
Propose a suitable eCOA build implementation, e.g., by using the relevant triggers and proposing appropriate edit checks that will ensure data quality.

Optimize the collection of caregivers’ data and improve their clinical trial journey

We offer supportive material to engage caregivers throughout the clinical trial.
We help you select the most relevant ObsROs for your pediatric clinical trial.
We help you reduce the burden for patients and families by offering the same device to capture both patient and caregiver data.
We offer multiple modes of eCOA collection to provide study participants with a choice to use a preferred option and to improve compliance.

Simplify your complex pediatric trials by using our robust technology tailored to manage complex eCOA builds

We are able to program relevant complex branching logic to ensure data collection and integrity.
Our Clin’form eCOA solution manages multiple-questionnaire visits and complex score calculations.
We are used to managing numerous questionnaire versions and translations across broad age groups.
We provide the management and audit trail of multiple user accounts for ePROs, eObsROs, and eClinROs.