UCLH creating a toolkit to make more clinical trials open to young people

A new research project spearheaded by the Cancer Clinical Trials Unit (CCTU) at UCLH is trying to make more places on clinical trials available to young cancer patients aged between 16 and 24 years. 

This group is often under-represented in clinical trials and this is associated with lesser improvements in survival.  

The CCTU has received funding from NHS England's Integrated Care Systems Research Engagement Network (REN) to co-create a toolkit with young people as partners to help investigators design TYA inclusive trials. 

This will include appropriate age-eligibility based on biology, information on specific regulatory concerns, safety and toxicity, the nuances of approaching young people about research and how to improve acceptability of trial design by involving young people as patient involvement partners in trial design.   

UCLH is one of the largest specialist centres in Europe for teenagers and young adults (TYA) with cancer and has a dedicated team within CCTU working to recruit young patients to trials.  

It is also an international leader in TYA care and research, and has been investigating barriers to recruitment for young people for around 20 years. A team of UCLH researchers published a seminal paper in 2014 identifying five barriers ‘The 5As’ which has served as a model for intervention development. 

Availability of trials: Young people experience rarer cancers, not common in older adults meaning less trials are available. 

Accessibility of trials: Young people may not be treated where relevant trials are open, and healthcare professionals may not offer young people trials as they feel they have too much going on already. 

Awareness: Young people and professionals may not know what trials are available, there is no national database of open trials, where they are recruiting, and a list of eligibility criteria. 

Acceptability: If professionals don’t believe in the study question or design they are unlikely to offer the trial to young people. Similarly if the study design is not acceptable to young people they are less likely to agree, for example, if the trial involves more hospital visits or longer treatment. 

Appropriate: The age-eligibility of trials tend to reflect whether it originates from an adult or children’s group. Adult trials tend to have a lower age of 18 years.  

Senior research fellow Lorna Fern, who is leading the project, said: “We previously identified that 75% of currently available trials for TYA have a lower age of 18 years, therefore excluding younger teenagers. We have also shown that amending the age-eligibility of open trials increases TYA recruitment.” 

Dr Fern added: “The minimum age of 18 years in adult trials is a hangover from the past when children’s and adult’s services were separated, leaving young people aged 16-17 in limbo. 

“The legal age for consent to research in the UK is 16 years and we found many trialists are willing to lower the age eligibility of adult trials when given advice and support. This is the aim of our toolkit. Together, I hope we can significantly increase the number of trials available for young people.” 

The project has recruited young people nationally from existing patient groups to take part. The young people met in March this year to discuss how they want to work as partners within the project and to discuss some of the toolkit content. 

One of the young person partners, Katharina Bucher, said: "I’m proud to have lent my voice to a cause I deeply care about: making research opportunities accessible to as many people as possible. I hope this project opens doors for an often-overlooked group to take part in cancer research that could help improve, or even save, their own lives or someone else's in the future."  

The national multi-disciplinary stakeholder group working on the project includes UCLH oncology manager Tara Searle, data manager Ellie Baker, lymphoma team lead Lauren Booker, volunteer Quincy D’Souza and clinicians Dr Victoria Grandage, Professor Rachel Hough, Professor Sandra Strauss, and Professor Rachel Taylor.