Ethics, Governance and Collaborations

Establishing clinical trials involving both adult and paediatric participants can be difficult to navigate.

How do I get ethics and governance approval to open an AYA clinical trial?

The Adolescent and Young Adult (AYA) Research Ethics and Governance Guideline provides a path to successful approval of clinical trial protocols that have an age eligibility, encompassing both adult and paediatric participants.

The guideline includes information on:

• Importance of justification of age eligibility based on disease biology
• Consent processes for paediatric participants
• Selecting an appropriate Human Research Ethics Committee
• Protocol amendments to broaden age eligibility in currently open trials

How can we get paediatric and adult oncology teams to communicate more about clinical trials?

The Paediatric-Adult Oncology Framework assists in the establishment of deliberate relationship-building between paediatric and adult oncology.

Focussed on systems-level issues, these ‘AYA craft groups’ aim to:

• Ensure clinician awareness of clinical trials on both sides of the paediatric-adult care divide
• Avoid duplication of trials between paediatric and adult oncology

In addition, AYA craft groups present opportunities to build collaborative research relationships; potentially leading to an increased number of investigator-initiated trials, designed to accommodate AYA participation.