“If I hadn’t had the clinical trial, I wouldn’t have been able to go on the transplant and ultimately, I think I wouldn’t have gone into remission.” – Tash, participant in a clinical trial for treatment of lymphoma when aged 15
Fair access for everyone to the best treatment, and better access to clinical trials: these are two of the top priorities for Victorians when it comes to cancer care. When Cancer Council Victoria recently took part in a consultation with the Therapeutic Goods Administration (the TGA), part of whose role is to regulate clinical trials, we based our submission on these concerns.
We know that cancer kills more teenagers and young adults in Australia than any other disease. Clinical trials play an important role in providing treatment options for people affected by cancer. Many people with cancer are now living longer, with a better quality of life due to the treatments developed in clinical trials. Strict age limits have meant that people under 18 have not been able to take part in trials, even though some cancers affect people over 18 and people under 18 in very similar ways. The fact that younger people have not been able to take part in clinical trials means that may be denied or have delayed access to potentially effective treatments – and outcomes. It is a health equity issue.
The TGA, as part of its regular consultations into possible changes to regulatory requirements and practices, asked for feedback on whether Australia should follow the European Union and adopt the American “Considerations for the inclusion of adolescent patients in adult oncology clinical trials: Guidance for industry”, the Food and Drug Agency’s guidelines for including people aged under 18 in clincial trials.
Our recommendation
Cancer Council Victoria supports the TGA’s proposal to adopt the FDA’s “Considerations for the inclusion of adolescent patients in adult oncology clinical trials: Guidance for industry”. Adoption of the FDA Guidance, as applicable to the Australian health sector, will provide an important foundation for adolescent patients to access therapies and outcomes available in adult cancer clinical trials.
UPDATE: On March 11, 2020 we were notified that these recommended guidelines were adopted which will hopefully make it easier for adolescent patients in Australia to access therapies and outcomes available in adult oncology clinical trials
Read our full submission here.