Fostering Age Inclusive Research (FAIR trials)
Led by Nathalie Gaspar, Gustave Roussy and Chris Copland, Unite2Cure
Presentation at the 6th ACCELERATE Annual Conference
- Identify successful protocols that might open during the year 2017
- Raise awareness
- Create tools to facilitate the understanding of the issues
- Gain endorsement of the adolescent strategy.
Composition of Group: Guillaume Bergthold, Debbie Binner, Christina BucciRechtweg, Christopher Copland, Nathalie Gaspar, Lynley Marshall, Christophe Massard, Michelle Rashford, Eve Mengou, Rosanna Ricafort, Gianluca Rossato, Cesare Spadoni, Jeffrey Skolnik, Maud Toulmonde, Max Williamson
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 who have seen the least improvement in cancer survival rates in recent decades. Why has this been so? One 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; however ans of December 2015, only six patients had been recruited (Gaspar et al, 2018).
It is because of these kinds types 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.
The web page is one of the channels we will use and, although currently in a basic state, it 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.
Publications by ACCELERATE and Key Papers
Gaspar, N. et al., 2018. Joint Adolescent-Adult Early Phase Clinical Trials to Improve Access to New Drugs for Adolescents with Cancer Proposals from the Multi-stakeholder Platform-ACCELERATE. Annals of oncology: official journal of the European Society for Medical Oncology / ESMO.
Gore, L. et al., 2017. Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group. Journal of clinical orthodontics: JCO, 35(33), pp.3781–3787.
Chuk, M.K. et al., 2017. Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents. Clinical cancer research: an official journal of the American Association for Cancer Research, 23(1), pp.9–12.
Gaspar, N. & Fern, L., 2016. Increasing Access to Clinical Trials and Innovative Therapy for Teenagers and Young Adults with Cancer – A Multiple Stakeholders and Multiple Steps Process. Progress in tumor research, 43, pp.38–49.
Whelan, J.S. & Fern, L.A., 2008. Poor accrual of teenagers and young adults into clinical trials in the UK. The lancet oncology, 9(4), pp.306–307.