MAR 28, 2022 3:00 AM PDT

FDA Encourages Inclusion of More Older Adults in Cancer Clinical Trials

WRITTEN BY: Katie Kokolus

While cancer is a disease that inflicts people of all ages, it is often considered a disease of old age. The science to support this paradigm is partly explained by genetic mutations known to accumulate over time. Since mutations can lead to cancer, it makes sense to expect more diagnoses in older individuals.  Exposure to carcinogens can also lead to cancer diagnoses, and these cancers can develop after years of exposure. Further, chronic conditions that increase cancer risk, including diabetes, obesity, and ulcerative colitis, also increase with age.    

Indeed, the statistics support cancer being a disease of age.  Incidence of some of the most common types of cancer, including lung, prostate, breast, colorectal, bladder, acute myeloid leukemia (AML), and chronic myeloid leukemia (CML), steadily rise in patients over 50.  Further, more than half of the diagnosed cancers occur in those over 65

So, in summary, there is a plethora of scientific and statistical evidence supporting the increased risk of cancer development in elderly patients. Given this, you might be surprised to learn that older adults are underrepresented in clinial trial testing new cancer therapies. In recognition of this discrepancy, the Food and Drug Administration (FDA) released new guidance earlier this month emphasizing the importance of including adults, particularly those 75 years and older, in cancer clinical trials. According to the release, the guidance is intended to “assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of cancer clinical trials.”

The recommendation includes all phases of clinical research, including early clinical development, clinical trials, and postmarket.  One specific piece of advice focuses on developing recruitment strategies targeted at older individuals.  For example, adding clinical trial sites located in community-based settings could be more accessible for those over 75 and thus may increase their participation. 

A recent piece in ScienceInsider interviewed oncologists who praised the guidance as a significant step towards a long-needed challenge in cancer research. Although the FDA’s direction isn’t binding, it shows a commitment from the Federal level to tackle the noticeable discrepancy in the clinical translational pipeline. Shifting clinical trial design to better target the intended population of the intervention under investigation will ultimately improve treatment options for the growing population of older individuals.  


Sources: British J Cancer, J Clin Oncol, Am J Prev Med, ScienceInsider

About the Author
Doctorate (PhD)
I received a PhD in Tumor Immunology from SUNY Buffalo and BS and MS degrees from Duquesne University. I also completed a postdoc fellowship at the Penn State College of Medicine. I am interested in developing novel strategies to improve the efficacy of immunotherapies used to extend cancer survivorship.
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