Eliminating age restriction in cancer clinical trials

Appropriate representation in clinical trials is essential to ensure that results can be generalised, and trial benefits translate to treatment benefits for all patients. Inequalities in access to cancer research for young people are implicated in poorer outcomes for this group.

The Teenage, Young Adults and Germ Cell Tumours Clinical Studies Group (CSG) identified a number of barriers to recruitment for young people – one of these was the age parameters which were applied to cancer clinical trials, in particular adult studies which routinely had a lower age eligibility of 18 years. However, following enquiries and investigation, the group found that there was no scientific rationale for this and that it had grown out of the historical boundaries around paediatric and adult cancer are and was just ‘always done that way’.

To change this the CSG approached Cancer Research UK, as the biggest funder of cancer clinical trials in the UK. They suggested that practice could be changed by asking new investigators to justify the use of age as inclusion or exclusion criteria at the point of study design and funding submission.

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. This has improved trial availability for older teenagers with cancer.

A knock-on effect of this work is that many of the investigators, as well as reviewing their lower age eligibility criteria, also removed their upper age eligibility criteria – consequently improving trial availability for elderly patients as well.

This work currently still only applies to clinical trials funded by Cancer Research UK. However, the Teenage, Young Adult and Germ Cell CSG has secured funds to re-engage with widening this work 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*.


*FDA statement citing this work.