Older adults with cancer are consistently precluded from participating in clinical trials for promising new treatments. A multi-pronged approach is required to ensure trials are developed for all patients, including paying specific attention to inclusion/exclusion criteria and creating clinically meaningful endpoints that can enhance enrollment efforts in underserved populations.
Advancing age is the biggest risk factor for cancer. According to the National Cancer Institute, the median age at which cancer is diagnosed in the United States is 66 years. One-quarter of new cancer cases are diagnosed in people aged 65 to 74. An aging population is expanding this demographic trend. By the year 2030, 70 percent of all cancers are expected to occur in adults age 65 and older. Understanding how emerging cancer treatments can affect older adults is critical for the delivery of high-quality, patient-centered care.
However, older adults are consistently precluded from participating in clinical trials for promising new treatments. A 2019 analysis of more than 300 oncology randomized clinical trials found trial participants to be significantly younger than patients in the general population with the same tumor types. Authors of the report, published in JAMA Oncology, characterize the age disparity they identified as “pervasive and worsening.” In the authors’ analysis of 262,354 participants enrolled in 302 oncology clinical trials between 1994 and 2015, the median age of participants was 6.49 years younger than the median age of all patients with the same cancers.
There are multiple reasons this gap exists. In general, eligibility criteria for clinical trials are developed to ensure the safety of trial participants. However, overly restrictive eligibility criteria can create barriers to patient enrollment, resulting in lower patient accrual and decreased generalizability of trial results.
The U.S. Food and Drug Administration (FDA) has published guidance statements for cancer clinical trial eligibility criteria to safely include patients, like those older than 65, who have historically been excluded from trials. This guidance promotes broader eligibility for clinical trial enrollment and a more generalizable and informed therapeutic intent.
Another effort important to including the perspective of older patients with cancer is capturing their experience with clinical trials and sharing it with their providers. It is import to clinical trial outcomes to understand the patient experience throughout the clinical trial period. In 2020, the FDA Oncology Center of Excellence announced the launch of Project Patient Voice, an online platform that enables patients and their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials. This information can be used by the cancer clinical team to provide additional information about the patient experience of specific cancer therapeutics and ultimately shape treatment decisions.
A multi-pronged approach is required to ensure clinical trials are developed for the patients most in need. Careful attention to inclusion/exclusion criteria and clinically meaningful endpoints (i.e., patient-reported outcomes) are only two methods that can enhance the trial enrollment of older adults. Developing protocols specific to vulnerable older adults requires institutions and cancer cooperative groups to work in concert to develop best practices.
This blog is adapted from an article by Ashley Rosko, MD, that appeared in the August 2020 issue of Research Review. Dr. Rosko is an associate professor in the Department of Internal Medicine at The Ohio State University (OSU), medical director of the Oncogeriatric Program at the OSU Comprehensive Cancer Center-James, and co-director of the Cancer and Aging Resiliency Clinic at the James.
