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Too old for paediatric trials, too young for adult trials

A recent report published by the UK’s Teenage Cancer Trust has discovered that patients aged between 13 and 24 are missing out on potentially life-extending clinical trials due to stringent age restrictions which mean they are often overlooked for both paediatric trials and adult trials. Although paediatric trials can include participants up to 18 and adult trials can include participants aged 18 and older, participants aged between 13 and 24 years remain underrepresented in both categories.

Data obtained from GlobalData’s trials intelligence platform reveals that participants between 13 and 24 were included in only 0.04% of paediatric/adult oncology clinical trials where either the minimum age for eligibility was 13 years or the maximum age for eligibility was 24 years. However, actual figures may even be lower as this figure includes trials that may have a minimum eligibility criterion of up to 24. Trials matching these criteria reached a 20-year high for trial initiations in 2023, which will hopefully mark a turn for 13 to 24-year-olds accessing innovative clinical trials

Novel study designs such as pragmatic trials may hold the key to tackling this disparity. Unlike traditional trials that have historically exclusively selected patients who meet rigorous inclusion/exclusion criteria, pragmatic trials aim to include study participants who reflect the real-world patient population and would most likely benefit from the treatment, as their experience will most closely represent what a typical person may experience. Because of this, clinical trials utilising a pragmatic design may be less stringent on meeting specific age criteria and instead focus on representing the real disease population. Similarly, adaptive trial designs may combat concerns regarding age-related safety, as these allow for the features of the trial to be changed as evidence is collected.

Beyond the age restrictions, patients aged between 13 and 24 are already more likely to be suffering from a rare disease indication that is severely underfunded by pharmaceutical companies due to the lack of profitability. The Teenage Cancer Trust is therefore calling for the age limits on trials to be medically justified.

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