Why FAIR Trials?

Our children, it is said,  are our future. So it is surprising to learn how far research into young people’s cancers trails behind that for adults. However, of all age groups, it is adolescents that  have seen the least improvement in cancer survival rates in recent decades. Why has this been so? One straightforward reason is that many clinical trials simply exclude those under the age of eighteen, not for reasons of science or safety but because ‘this is the way things have always been done’   In a study in 2016, Whelan and Fern demonstrated that out of  forty nine trials  of cancers common in teenagers and young adults, only six had age eligibility criteria that corresponded to the biological age range of the diseases.  There is thus an urgent need for the cancer research community to make trials more inclusive, not only because this would be better science but because it could save lives.

Clinical trials that are ‘adult-only’ hold back young people from getting access to new  treatments. For example, a new drug for Hodgkin’s Lymphoma was approved for adults in 2012. However, a paediatric trial for the same drug and the same illness was still ongoing in 2016. Current practices also lead to ghost trials where there are too few patients for any useful data to be collected. This occurred with a drug for the treatment of melanoma, which was approved in Europe for adults in 2012. A trial for adolescents was opened in 2011 in ten countries and four  continents. As of December 2015, only six  patients had been recruited (Gaspar et al, 2018).

It is because of these kinds of problems that FAIR Trials has been set up – to facilitate age  inclusive research. Our key proposal  is for  the age of entry to be reduced to 12 years in adult early phase studies (where medically justified). This may sound a bold target but there is no great obstacle in terms of law, regulation or safety. The issue, rather,  is one of awareness and will within the research community. The working group therefore intends to work for a culture change through, for example:

  • identifying trials that are truly age inclusive and publicising these success stories
  • engaging with ethics committees, national and international research networks and with industry
  • stating our case live, in the media  and online.

This web page is one of the channels we will use and, although currently in a basic state, will be developed in the coming months using a range of media to address specific key groups: pharma, clinicians, regulators and, of course, patients and families.  To begin with, we are providing in our list of key papers easy access to the growing body of evidence of the need for age inclusive research.

Our core membership is small but we hope to create a wider circle of supporters. If you would like to get involved or find out more, e-mail me at  chriscoplandatyork@gmail.com

Together we can make change.

 

Chris Copland

Parent Representative



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