Age limits in clinical trials are a barrier to equitable cancer care

there continues to be a lack of awareness about this issue of cancer in older adults and few investments in the health services required to respond to the unique needs of this group
16 November 2022

Older people are vastly underrepresented in clinical trials that set the standards for the efficacy and safety of cancer treatments. What steps can be taken to close this care gap?

People over 65 represent more than half of all cancer cases worldwide, yet they often do not receive the same level of personalised care that other populations may enjoy. This is due to a number of factors as age adds a layer of complexity to living with cancer. 

Early symptoms can be attributed to everyday pain or minor illnesses associated with old age, and older adults are more likely to suffer from other chronic conditions and non-communicable diseases, such as high blood pressure or diabetes. 

Disparities in cancer care for older adults

Learn more about the challenges faced by health systems in delivering, and older adults in receiving, adequate cancer care, as well as the work UICC is doing in this area as part of its partnership with Sanofi.

Nevertheless, there continues to be a lack of awareness about this issue of cancer in older adults and few investments in the health services required to respond to the unique needs of this group – including the participation of older people in research, where a major challenge is the lack of data on the kinds of treatments that work and are tolerated in older patients. 

Indeed, older adults are vastly underrepresented in clinical trials that set the standards for the efficacy and safety of cancer treatments. This is both an issue of equity and quality of care – that older adults have access to a level of care that responds to their needs and expectations.

In 2011, the European Medical Agency (EMA) launched the geriatric medicines strategy, with guidelines to improve the design and conduct of clinical trials in addressing the requirements of older people in medicine development. 

In March 2022, the US Food and Drug Administration released guidance for the industry regarding the inclusion of older adult patients in clinical trials of cancer drugs. The guidance includes recommendations for ensuring adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population, emphasising the particular importance of including adults over age 75 years, including those presenting with cardiac issues and other co-morbidities.

Indeed, two studies have found that roughly one third to one half of clinical trials assessed excluded older adults indirectly due to co-morbidities. Excluding these individuals has the potential to distort the results of research and clinical trials, as their sample populations do not reflect the incidence in the general population.

Recruitment and retention issues also constitute barriers to including older adults in clinical trials. Older people themselves may be reluctant to participate, often citing as reasons the fear of further harming their health or that they are too old or they have reservations concerning the efficacy of novel cancer treatments. Concerns over the invasiveness and time demands of studies further affect older adults’ willingness to participate in clinical trials.

There are additional challenges to successful recruitment and retention. Older people with certain co-morbidities and disabilities require assistance to travel to and navigate the centre where the trial is taking place. Or the person may need someone to sign a consent form depending on their level of cognitive ability.

Older adults may also more often fall ill or suffer a debilitating health condition such as stroke or heart attack that requires hospitalisation – or even cause death. They are therefore at greater risk of failing to maintain consistent meetings as the trial requires or to complete the trial. 

At the London Global Cancer Week taking place 14-18 November, UICC is hosting a hybrid panel event on “Including older adults in cancer research” as part of its cancer and ageing programme in partnership with Sanofi to address these challenges. The session will explore how to improve the participation of older adults in cancer research and is being held on Friday 18 November at 4.30pm GMT at the River Room, King's College Strand Campus (remote participation possible). 

Speakers:

  • Dr Richard Sullivan, Director, Institute of Cancer Policy, Kings College London, United Kingdom
  • Dr Nicolò Battisti, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust and President of the International Society of Geriatric Oncology (SIOG), UK
  • Dr Charlotte Pawlyn, Institute of Cancer Research, UK
  • Mr Tom Gentry, Senior Health Influencing Manager, HelpAge UK “

Chair: Dr Matti Aapro, Board Member International Society of Geriatric Oncology and former President of the European Cancer Organisation, Switzerland

Last update: 
Wednesday 16 November 2022
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