According to a recent article on the Washington Post, more than 60% of cancer patients are older adults and that number could increase to 70% by 2040. However, seniors are rarely involved with clinical trials, leading to uncertainty with how treatments will affect them. According to a Food and Drug Administration analysis, 60% of clinical trial participants between the years 2005-2015 were less than 65 years old.
Clinical trials investigate the safety and effectiveness of new drugs and therapies, and their findings ultimately help guide medical practice. Nonetheless, older adults are not often included in research studies. This is especially true for cancer patients in their 70s and 80s, according to FDA’s data:
- While 19 percent of breast cancer patients are 75 or older, only 4 percent of breast cancer clinical trial participants are of this age.
- Although 33 percent of colon cancer patients are in the 75-and-older group, a mere 8 percent of patients studied by researchers fell into that age group.
- While 37 percent of lung cancer patients are 75 or older, only 9 percent of people of that age are represented in lung cancer clinical trials.1
Stuart Lichtman, a professor of medicine at Weill Cornell Medical College concluded that, “It’s difficult to practice evidence-based medicine in an older population because the data isn’t there.”1
Unfortunately, its not just cancer. The problem persists across medical conditions that disproportionately affect seniors. Many people assume that products only need to be tested in younger populations, but older adults respond to medications and interventions differently based on their physiology.
Older adults do face some barriers that prevent them from participating in clinical trials. For example, Alzheimer’s disease research studies also have difficulties enrolling older people due to the fact that less than one third of people effected by Alzheimer’s are eligible to join clinical trials according to Keith Fargo, director of scientific programs at the Alzheimer’s Association.1 The ineligibility is mostly due to the multiple illnesses seniors may have that complicate the study’s results. In addition, older adults may live alone and be unable to travel to the study site for tests and procedures.
Additionally, significant responsibility falls on physicians who fail to ask older patients if they would like to participate in clinical trials. Richard Schilsky, Chief Medical Officer for ASCO attributes this to the “concern that older patients might be unable to comply with a trial’s requirements, which are usually quite rigorous, and concern that specified therapies might be too toxic.” 1
For older adults hesitant about joining a clinical trial, the National Institute on Aging created materials intended to facilitate the decision making process.
For those who want to look for trials on their own, NIH sponsors ClinicalTrials.gov, which contains a database of ongoing studies around the world. However, Schilsky recommends that patients consult with his or her doctor before enrolling in a study.
Pearl IRB delivers superior central IRB review services that effectively balance the needs of human subjects, sponsors and sites. Our AAHRPP accredited independent review board can promptly review your next study to prepare for human subject trials. Contact us today to start a conversation.