Young Adults to Paediatric Trials
How can we get young adults to paediatric oncology trials?
Paediatric oncology trials often have an age eligibility that extends into adulthood. However, these are generally open only at a paediatric hospital, which prevents young adults (18-25y) from accessing them because they are over-age for care at a children’s hospital.
There are two possible solutions to this.
The first is what we have termed the ‘trials to patients’ model, in which young adults would be able to remain in their adult oncology centre, but still participate in the clinical trial. While this solution is considered the best for the patient, it requires systems-level collaboration and change between paediatric and adult cancer centres which will take time to establish and are a focus of ongoing work.
Models being explored include:
- Shared clinical trial governance arrangements between paediatric and adult oncology clinical trial units
- A teletrials model whereby telehealth methods are used to bring the paediatric trial to the young adult patient without having to open the trial at the adult centre.
The alternative solution, which bridges the gap until further progress can be made with the ‘trials-to-patients’ model, and may be necessary longer term in certain circumstances, is the ‘patients-to-trials’ model.
In this model, we have created a standard operating procedure (SOP) for application to paediatric hospital executive for special access to the hospital for a young adult to participate in a paediatric trial. The SOP requires the completion of an access request form that provides hospital executive with the information they require to assess each request on a patient-by-patient basis.
The process enables both a swift response and a transparent and documented outcome:
The SOP has been activated in our local setting and has enabled four young adult access permissions in the first four months of operation.