Older Adults with Cancer Not Represented Proportionately in Clinical Trials According to Study

There was little effort being made to improve representation for older adults in clinical trial enrollment for new cancer drugs, even if the treatment is for a disease that disproportionately impacts patients this age with cancer, according to a study published in CA: A Cancer Journal for Clinicians.

According to lead author of the study, Mina Sedrak, MD, MS, 2 in 5 Americans with cancer are aged 70 or older, but fewer than 25% of patients enrolled in clinical trials registered with the FDA fall in this age group.

"There is currently no incentive to establish real-world effectiveness among older adults. Older adults need a seat at the table," Sedrak, lead author of the study and deputy director of the Center for Cancer and Aging at City of Hope, said in a press release.

Researchers from City of Hope reviewed over 8500 studies evaluating the barriers that exist that make it difficult for older adults to participate in clinical trials. Of that population, 12 articles cited complex, interrelated problems as some of the root causes. These included stringent eligibility criteria, physician concern for toxicity, ageism, transportation and caregiver burden.

Further, of those 8500 studies evaluated, 1 implemented an intervention with the goal of increasing the enrollment of adult patients with cancer in clinical trials. While this strategy was ultimately unsuccessful, the data suggests that a lack of effective strategies exists to improve participation and representation for this older cohort of patients in clinical trials.

"Ask your doctor about clinical trial opportunities when you're diagnosed with cancer and do your own research because there may be an option that you haven't heard about,” said Sedrak. “It may benefit you, but perhaps your doctor may not have considered you for the investigational trial."

Moving forward, the researchers suggested that clinical trials must ask appropriate questions that are tailored to older adults with cancer and address the needs of this cohort. Not only do they recommend this to researchers enrolling older adults, but they suggest that all oncologists and primary care providers should keep this in mind.

"We don't know enough about treating our largest group of cancer patients,” William Dale, MD, PhD, the study's senior author and an oncologic geriatrician at City of Hope, said in a press release. “In the midst of the COVID-19 pandemic, when enrollment in trials is lower than ever due to isolation and distancing practices, actively including older adults in clinical trials is incredibly important."

Reference:

Study details strategies to address barriers keeping older adults out of clinical trials [news release]. Duarte, California. Published October 1, 2020. https://www.eurekalert.org/pub_releases/2020-10/coh-sds092920.php. Accessed October 15, 2020.