Ensuring the participants taking part in clinical trials are representative of the disease being studied is essential to ensure that results can be generalised, and that trial benefits can be translated to improved treatments and outcomes for all patients. Inequalities in access to cancer research for young people are implicated in poorer outcomes for this group.
NCRI’s Teenage, Young Adults and Germ Cell Tumours Group identified several barriers to the recruitment of young people to clinical trials – one of these was the age parameters which were applied to cancer clinical trials, adult studies routinely had a lower age eligibility of 18 years. However, following enquiries and investigation, the group found that there was rarely any scientific rationale for this and that it had grown out of the historical boundaries around paediatric and adult cancer care.
Improving the representation of young adults in clinical trials
To address this the Teenage, Young Adults and Germ Cell Tumours Group approached Cancer Research UK, as the biggest funder of cancer clinical trials in the UK to suggest that the funding application processes could be amended so that new investigators should be asked to justify the use of age as inclusion or exclusion criteria at the point of study design and funding submission.
As a result of this engagement, researchers applying to Cancer Research UK for funding for a clinical trial are now asked for scientific justification for both upper and lower inclusion age limits in their patient recruitment criteria. If a lower limit is required, researchers are instructed to set this at 16 rather than 18. Amending age eligibility criteria will improve trial availability for older teenagers with cancer.
Having a lower age barrier of 18 years for adult cancer trials is well-intentioned, but it doesn’t reflect the biological reality of cancer and prevents young people from accessing crucial new drugs in clinical trials. By dropping the age of CRUK clinical trials, we are giving more young patients access to potentially lifesaving research and improving the power of these studies to show which drugs work best in treating their cancer.
Max Williamson, NCRI Consumer Forum member and member of NCRI TYA & Germ Cell Tumours Group
This work also had a knock-on effect on representation of the elderly in clinical trials. Many of the investigators, as well as reviewing their lower age eligibility criteria, also removed their upper age eligibility criteria – consequently also improving trial availability for elderly patients.
Growing consensus on removing lower age limits
This work has evolved and responsibility for tracking recruitment and ensuring young people are recruited to clinical trials has transferred to the NIHR Clinical Research Network, the network has a target to recruit 50% all young people diagnosed with cancer into a clinical trial by 2025. The NCRI Teenage, Young Adults and Germ Cell Tumours Group are now looking to develop interventions to improve the recruitment of young adults into clinical trials.
This work resulted in a major shift in thinking around age criteria in clinical trials. There has also been international interest after the Food and Drug Agency released a statement in December 2016 encouraging the inclusion of adolescents in adult studies, citing this work as an example.