Redesigning clinical research to improve outcomes for older people

Dr Richard Simcock – Consultant Clinical Oncologist, Sussex Cancer Centre, and Chair of Macmillan Expert Reference Group for Cancer in the Older Person

 

 

Most of us are proud to practice evidence based medicine yet our largest cohort of cancer patients has an insufficient evidence base; older people.

Lodged in the middle of the 96 recommendations of the 2015 Independent Cancer Task Force is the ambition that there should be “..research protocols which enable a better understanding of how outcomes for older people could be improved

There is much that needs to be improved; older patients are more likely to be diagnosed late and more likely via an emergency presentation, they are less likely to receive active therapy than younger patients and have poorer survival than age matched cohorts from European neighbours. The scale of the problem is outlined in a recent CRUK report.

Research is a tool that should improve the cancer care we give, however with older adults we face a paradox; research is conducted with cohorts of patients who are younger and fitter than the majority of those who go on to receive those therapies once the research is published. Trials dedicated exclusively to older people form less than 4% of the current NCRI portfolio.

Alongside these inclusion biases in modern cancer research there are a multitude of other problems including the incorporation of comorbidity and frailty into trial design, understanding differences in pharmacokinetics, the appropriate deployment of (scarce) geriatric expertise and a sophisticated understanding of patient preference. It is an inequitable mess.

To start to provide the solutions requested by the Cancer Task Force the NCRI convened a workshop in partnership with NHS England, of oncologists, geriatricians, researchers, consumers, charity representatives and other experts to consider these complex issues. The report from that workshop published here helps define pathways that should redefine our approaches.

The NCRI workshop looked at the problems laterally, positively and inclusively. What trial designs allow for the study of the frail? How can comorbidities lead to a stratification rather than an exclusion? How are consumer views incorporated in designing trial endpoints of value? The document contains many suggestions that triallists could start to use immediately.

We have existing tools which are underused or ignored in trial design. Comprehensive Geriatric Assessment (CGA) is an interesting case in point. We already have enough research to show that CGA has utility. The task now is to build trials using CGA in patient selection and alongside our research interventions.

Too often ageing population is framed negatively (the ‘silver tsunami’ etc.) yet the continued rise in life expectancy is due to advances in modern health and social care that should be celebrated. If we are lucky we will all be old one day. This universal vested interest should be enough that we immediately start taking the time to design research that is inclusive of older people and that, as one workshop delegate demanded, there is a trial for every older person.

 

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