Adolescents to Adult Trials
For adolescents (aged 15-17 years), access to an adult cancer centre is not a barrier to adult cancer trial participation in the Victorian setting, since most adult cancer centres routinely admit patients from 15 or 16 years of age. Rather, the primary barrier is that adult cancer trials very rarely have an age eligibility below 18 years.
To begin to alleviate this, the VCCC Alliance approached the Australian Therapeutic Goods Administration (TGA) and requested consideration to adopting the US Food and Drug Administration (FDA) guideline: Considerations for inclusion of adolescent patients in adult oncology clinical trials – Guidance for Industry.
The guideline was adopted by the TGA for Australian use in February 2020. Adoption of the FDA guideline supports and facilitates a lowering of the age eligibility in relevant Australian adult cancer trials to include adolescents.
It is anticipated that, over time, use of the guidance will lead to an increase in availability of clinical trials for the approximately 50 adolescents (aged 15-17 years) who are diagnosed with cancer in Victoria every year.