Dear Voornaam We need your views on a proposed guideline to increase access to trials for adolescents with adult-type cancers. The Victorian Comprehensive Cancer Centre (VCCC) Increasing Adolescent and Young Adults (AYA) Access to Clinical Trials Program aims to identify and alleviate barriers for young people to access trials. It is well established that people in the AYA age bracket, 15-25 years, enrol in cancer clinical trials less frequently than younger children or older adults. This lower participation rate is correlated to lower cancer survival gains. Why are adolescent patients with cancer restricted from clinical trials? Cancer Council Victoria statistics from November 2018 indicate that only three per cent of adult cancer treatment trials relevant to most common AYA cancer types were open to AYA younger than 18 years of age. This age limitation is based primarily on our social definition of the age of maturity, rather than on disease biology. A survey of Victorian Research Ethics and Governance offices indicated that few Human Research Ethics Committees (HRECs) require biologically-based justification of age eligibility when reviewing clinical trial protocols. This well-entrenched system represents a significant, but unnecessary barrier to clinical trial participation for adolescents. What can be done to open access to clinical trials for adolescent patients with cancer? Australia’s Therapeutics Goods Administration (TGA) proposes to adopt the US Food and Drug Administration (FDA) guideline on including adolescents in adult cancer trials. The guideline clearly sets out biologically- and ethically-based rationale for lowering age eligibility in adult cancer clinical trials to incorporate adolescent patients. What action can I take to contribute? The TGA is seeking consultation on the proposal to adopt the FDA guideline. Please read the guideline and let the TGA know of your recommendation to adopt by Friday 7 February 2020. Best regards Professor Grant McArthur Executive Director Victorian Comprehensive Cancer Centre
