We Must End Ageism in Cancer Clinical Trials

We Must End Ageism in Cancer Clinical Trials thumbnail

Older are underrepresented in clinical trials research. Here’s how we can change that

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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. Even if they have the latest medicines, treatments such as those for multiple myeloma may not work as well in patients who are of ethnic minority, especially older patients. The gap in care for older adults is wider due to racial, geographic, and economic barriers.

If age is “just a number,” what is standing in the way of older people obtaining high-quality cancer treatment? Lack of evidence from clinical trials that can inform oncologists about the best treatment options is one factor. Clinical trials have not provided much information about the effectiveness of cancer treatments in older people. This is due to the continued underrepresentation in clinical trials of older adults. 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. Therefore, treatment strategies are often based upon data from younger people.

Cancer societies and advocacy organizations have made a number of recommendations to address this 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 efforts, older people 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. Industry-sponsored trials had a lower median age, which further shows the importance of the pharmaceutical industry in ensuring that older people are accurately represented in future clinical studies.

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 offer a series of recommendations to ensure that patients in clinical trials are of the same age and ethnicity as those with the disease in real life.

  • 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. Healthcare professionals should consider creating an internal task force to support clinical trial teams and promote age diversity. Pfizer’s Diversity in Clinical Trials Center of Excellence was established by us. This center provides demographic data to drive enrollment that reflects real-world populations. It also supports the selection of appropriate trial locations early in the study design process. To ensure that clinical trials are appropriate for older patients and ethnic minorities, sponsors should use data from the early phases, real-world evidence, and translational studies. To ensure that we use the appropriate trial eligibility criteria and assessment criteria, we should partner with community-based physicians, geriatric oncology experts, caregivers, and patient representatives at all stages of study design.
  • Including study endpoints that are appropriate for older people and using geriatric assessment tools in trials that enroll people in this age group. Although most cancer trials focus on survival, some endpoints and patient-reported outcomes can help to paint a better picture of the treatment’s impact on older patients. Geriatric assessment data including movement, brain function, nutritional status and comorbidities can be used to help determine the risks and benefits of treatments for older people. It can also help pinpoint predictors that could lead to worsening diseases 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. Sponsors should offer soft skills training programs and communication tools to help patients, investigators, and doctors overcome communication barriers.
  • Building trust through tailored education. Maximizing trial participation among older adults and people from ethnic minorities will require broader patient engagement. Sponsors need to design and implement community-directed programs that are led by community health educators. They should also use the right tools. These programs can reach older adults via channels they trust. Communication must address fears of experimentation resulting from historical 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. My colleagues and I have used pooled analysis from multiple trials to generate and report safety and efficacy findings in larger numbers of older people in our breast cancer research.

My hope is that these key areas will help to increase inclusion of older adults, even those from ethnic minorities, in clinical oncology research. 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. A step in the right direction is making changes in the way older people are represented in research on cancer.

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

ABOUT THE AUTHOR(S)

    Dany Habr is senior vice president and chief medical officer at Pfizer Oncology overseeing the oncology portfolio and medical organization. He has co-authored 40 manuscripts and

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