We Must End Ageism In Cancer Clinical Trials

Cancer afflicts more older people than those in any other age group. In fact, over half of cancers diagnosed in the United States occur in those over the age of 65. That number is expected to reach 70 percent by 2030, as the population experiences an unprecedented boom of senior citizens. A growing number of targeted cancer therapies and immunotherapies are available today, but older people often don’t have access to these options, putting them at greater risk of dying from their disease. And even when they do have access to the latest medicines, these treatments, such as those for multiple myeloma, may not work as well in ethnic minority groups, especially in older patients. This gap in care for some older adults is even wider because of racial, economic, and geographic barriers. If age is “just a number,” what is standing in the way of older people obtaining high-quality cancer treatment? One factor is the lack of clinical trial evidence that can help oncologists make informed decisions about the best possible treatment options. Historically, clinical trials haven’t told us much about how cancer treatments work in older populations. This problem arises primarily from continued underrepresentation of older adults in clinical trials. Studies show that people 65 and older living with cancer represent only about 40 percent of enrollees in registration trials of new cancer therapies; such trials are used to determine the benefit and safety of a potential new therapy and are a critical step in gaining approval from the U.S. Food and Drug Administration. This imbalance is even starker for those 80 years and older, who represent only 4 percent of those included in registration trials. Consequently, treatment strategies are often based on data from younger people. Cancer societies, advocacy organizations, and regulatory agencies have made several recommendations to address this growing problem. These include various recommendations from regulatory and industry organizations like the FDA and the American Society for Clinical Oncology (ASCO) for leveraging research designs to generate evidence from older people with cancer and giving the FDA more authority to require research involving older adults. Despite these steps, older populations are still underrepresented. A recent analysis of 302 industry- and non-industry-sponsored clinical trials showed that overall, the median age of participants was around 6.5 years younger than the median age of those who had the disease in the general population. The median age was even lower in industry-sponsored trials, further demonstrating the key role that the pharmaceutical industry has in ensuring older people are accurately represented in future clinical trials. I co-authored three papers focused on improving diversity in clinical trials published in Cancer, Journal of the National Cancer Institute, and Hematological Oncology. They propose a series of recommendations to ensure the ages and ethnicities of patients in clinical trials reflect the ages and ethnicities of those living with the disease in the real world. Some recommendations include:

Reevaluating criteria for clinical trial enrollment—especially those that exclude people based on age. This is likely one of the main reasons for the lack of representation we see today. Alternate eligibility criteria that exclude patients based on factors such as functional status, organ function, and comorbidities, among others, contribute to the underrepresentation. Those of us in the healthcare industry should consider establishing an internal task force to support our clinical trial teams and promote age diversity. For example, we established Pfizer’s Diversity in Clinical Trials Center of Excellence, which provides demographic data to help drive enrollment that reflects the real-world populations and supports appropriate trial location selection early in the study design process. Sponsors should lean on data from early phase, real-world evidence and translational studies to make sure they design clinical trials that are suitable for people from ethnic minority groups and older patients. We should also partner with geriatric oncology specialists, community-based physicians, patient representatives, and caregivers during the different stages of study design to help ensure we are using appropriate trial eligibility and assessment criteria. Including study endpoints that are appropriate for older people and using geriatric assessment tools in trials that enroll people in this age group. While the goals of most cancer trials are focused on survival, the addition of certain endpoints and patient-reported outcomes in older people can paint a more accurate picture of how the treatment will affect this group. Geriatric assessment data, including movement, brain function, frailty measures, nutritional status, and comorbidities, collected during the trial can also help measure the benefits and risks of treatments in older people and better pinpoint the predictors that might lead to worsening disease and death. Increasing awareness and access to clinical trials among older people living with cancer. Beyond stringent eligibility criteria, a study analyzing perceptions among academic and community oncologists showed that older adults are usually not considered for clinical trial participation as a consequence of bias or unfounded health concerns. Older patients report a lack of information on the trials that are available to them. This is a problem. The adoption of digital and virtual tools brought about by the COVID-19 pandemic should be used to improve diversity of clinical trial participants, including those in rural areas or with limited mobility or access to research institutions. In areas where doctors, investigators and patients face communication barriers, sponsors should provide soft skills training programs and communication tools with appropriate messaging for age or ethnic minority groups. Building trust through tailored education. Maximizing trial participation among older adults and people from ethnic minorities will require broader patient engagement. Sponsors should design and implement community-directed programs led by community health educators and using the right tools. These programs can reach older adults through channels they already trust. The communications must address issues such as fear of experimentation stemming from historic exploitation in medical research. Reporting data that are specific to older people and ethnic groups that can be used to help oncologists make more appropriate treatment decisions. One approach my colleagues and I have taken in our breast cancer studies is the use of pooled analysis from several trials to generate and report efficacy and safety findings in larger groups of older people.

My hope is that action in these key areas will improve inclusion of older adults, including those from ethnic minority backgrounds, in clinical oncology research going forward. To further support efforts to tackle medical, policy, and societal barriers standing in the way of the best care possible for older people, Pfizer created a section on our This Is Living With Cancer online community, called “As We Age,” specifically for sharing resources and tools with people 65 and older living with cancer. Across the healthcare community, we have a responsibility to improve the quality of care for all patients. Change in the way that older people are represented in cancer research is a step in the right direction. This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.

If age is “just a number,” what is standing in the way of older people obtaining high-quality cancer treatment? One factor is the lack of clinical trial evidence that can help oncologists make informed decisions about the best possible treatment options. Historically, clinical trials haven’t told us much about how cancer treatments work in older populations. This problem arises primarily from continued underrepresentation of older adults in clinical trials. Studies show that people 65 and older living with cancer represent only about 40 percent of enrollees in registration trials of new cancer therapies; such trials are used to determine the benefit and safety of a potential new therapy and are a critical step in gaining approval from the U.S. Food and Drug Administration. This imbalance is even starker for those 80 years and older, who represent only 4 percent of those included in registration trials. Consequently, treatment strategies are often based on data from younger people.

Cancer societies, advocacy organizations, and regulatory agencies have made several recommendations to address this growing problem. These include various recommendations from regulatory and industry organizations like the FDA and the American Society for Clinical Oncology (ASCO) for leveraging research designs to generate evidence from older people with cancer and giving the FDA more authority to require research involving older adults. Despite these steps, older populations are still underrepresented. A recent analysis of 302 industry- and non-industry-sponsored clinical trials showed that overall, the median age of participants was around 6.5 years younger than the median age of those who had the disease in the general population. The median age was even lower in industry-sponsored trials, further demonstrating the key role that the pharmaceutical industry has in ensuring older people are accurately represented in future clinical trials.

I co-authored three papers focused on improving diversity in clinical trials published in Cancer, Journal of the National Cancer Institute, and Hematological Oncology. They propose a series of recommendations to ensure the ages and ethnicities of patients in clinical trials reflect the ages and ethnicities of those living with the disease in the real world. Some recommendations include:

Reevaluating criteria for clinical trial enrollment—especially those that exclude people based on age. This is likely one of the main reasons for the lack of representation we see today. Alternate eligibility criteria that exclude patients based on factors such as functional status, organ function, and comorbidities, among others, contribute to the underrepresentation. Those of us in the healthcare industry should consider establishing an internal task force to support our clinical trial teams and promote age diversity. For example, we established Pfizer’s Diversity in Clinical Trials Center of Excellence, which provides demographic data to help drive enrollment that reflects the real-world populations and supports appropriate trial location selection early in the study design process. Sponsors should lean on data from early phase, real-world evidence and translational studies to make sure they design clinical trials that are suitable for people from ethnic minority groups and older patients. We should also partner with geriatric oncology specialists, community-based physicians, patient representatives, and caregivers during the different stages of study design to help ensure we are using appropriate trial eligibility and assessment criteria.
Including study endpoints that are appropriate for older people and using geriatric assessment tools in trials that enroll people in this age group. While the goals of most cancer trials are focused on survival, the addition of certain endpoints and patient-reported outcomes in older people can paint a more accurate picture of how the treatment will affect this group. Geriatric assessment data, including movement, brain function, frailty measures, nutritional status, and comorbidities, collected during the trial can also help measure the benefits and risks of treatments in older people and better pinpoint the predictors that might lead to worsening disease and death.
Increasing awareness and access to clinical trials among older people living with cancer. Beyond stringent eligibility criteria, a study analyzing perceptions among academic and community oncologists showed that older adults are usually not considered for clinical trial participation as a consequence of bias or unfounded health concerns. Older patients report a lack of information on the trials that are available to them. This is a problem. The adoption of digital and virtual tools brought about by the COVID-19 pandemic should be used to improve diversity of clinical trial participants, including those in rural areas or with limited mobility or access to research institutions. In areas where doctors, investigators and patients face communication barriers, sponsors should provide soft skills training programs and communication tools with appropriate messaging for age or ethnic minority groups.
Building trust through tailored education. Maximizing trial participation among older adults and people from ethnic minorities will require broader patient engagement. Sponsors should design and implement community-directed programs led by community health educators and using the right tools. These programs can reach older adults through channels they already trust. The communications must address issues such as fear of experimentation stemming from historic exploitation in medical research.
Reporting data that are specific to older people and ethnic groups that can be used to help oncologists make more appropriate treatment decisions. One approach my colleagues and I have taken in our breast cancer studies is the use of pooled analysis from several trials to generate and report efficacy and safety findings in larger groups of older people.

Across the healthcare community, we have a responsibility to improve the quality of care for all patients. Change in the way that older people are represented in cancer research is a step in the right direction.

This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.