Trial Eligibility Key to Young Adult Cancer Patient Participation

Clinical trial eligibility criteria should be based on biological rationale to include participation of teenagers and young adults with cancer

medwireNews: Removing inappropriate age eligibility criteria from oncology clinical trials can help increase the number of teenagers and young adults participating in research, suggests a review published in The Lancet Oncology.

Speaking to medwireNews, lead author Lorna Fern, from the National Cancer Research Institute Teenage and Young Adult Clinical Studies Group, based at University College London in the UK, explained there are “true adolescent cancers” such as Hodgkin’s lymphomas but age eligibility for trials often truncate the age range.

“Patients should be eligible for a study based on the cancer type they have rather than how old they are”, she said.

Trial participation in Great Britain between 2005 and 2010 fell with increasing patient age, from 55% of patients aged 5 to 9 years to 30% of patients aged 15 to 19 years and just 14% of those aged 20 to 24 years.

But participation rates improved overall for children and young adults aged up to 24 years, with the greatest gain over the study period found for those aged 15 to 19 years, at a 13% increase in participation. A smaller, 5% increase was also reported for patients aged 20 to 24 years.

Of concern, just six of the 49 studies of cancers commonly found in teenagers and young adults had age eligibility criteria appropriate for the biological age range of the disease or including the full age range of patients affected.

But these trials were more likely to have comparable recruitment rates for patients aged 10 to 14 years and 15 to 19 years than other studies, although a deficit was still found for patients aged 20 to 24 years.

Based on their findings, the team now proposes a conceptual model to improve young adult participation in phase I and II trials and larger randomised studies.

By following the “Five As” framework, researchers can raise Awareness and ensure trials are Available, Accessible and Appropriate for young adults, the researchers say. Involving patients in protocol design can also help make sure trials are Acceptable to young patients who may have different priorities to those of other patient populations.

“The use of age as a barrier to enrolment in clinical trials can be mitigated by appropriate study design; however, this in itself will not be sufficient to improve recruitment”, Lorna Fern told medwireNews.

“Healthcare professionals need to ensure access to new treatments through availability in centres where young people are treated and be empowered to ask young people about taking part in research.”


Fern A, Lewandowski J, Coxon K, et al. Available, accessible, aware, appropriate, and acceptable: a strategy to improve participation of teenagers and young adults in cancer trials. Lancet Oncol 2014; 15(8): e341–e350. doi:10.1016/S1470-2045(14)70113-5

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