Australia’s Therapeutic Goods Administration (TGA) has adopted the US Food and Drug Administration’s (FDA) guidance for including adolescents and young adults (AYA, 15-25 years) into adult cancer clinical trials.
Almost all cancer clinical trials open for recruitment in an adult care setting have an age eligibility of 18 years or greater. Adolescents can develop adult-type cancers but are often excluded from participation in such trials based on age.
The VCCC Increasing Adolescent and Young Adult Clinical Trial Access Program has worked with the TGA to alleviate this significant access barrier.
The adoption by the TGA of the FDA’s ‘Considerations for the inclusion of adolescent patients in adult oncology trials – guidance for industry’ supports and facilitates, for the first time in Australia, a lowering of the age eligibility in relevant adult cancer clinical 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 300 AYA patients, who are diagnosed with cancer in Victoria every year.
For further information on the program, contact VCCC Program Manager, Justine Ellis, [email protected]
