No Hope for Older Patients in Cancer Clinical Trials Thanks to Bias

All life is precious; understandably, resources for clinical trials of many illnesses like cancer may be limited. Does eliminating older patients from these trials add to our clinical knowledge? I would offer that it doesn’t because a trial unless limited for a valid research reason to one set of patients, is flawed by a design that eliminates the elderly or older patients.

There are specific types of sampling for clinical trials or any research, and they are random, systematic, stratified, clustered, and convenience sampling, and the sampling type may result in older patients being excluded. There are other types of sampling, but these are the more usual. Convenience sampling is one where it is probably easiest to get the sample size required.

Of course, each clinical trial will also, in addition to their sampling method, have rule-in and rule-out criteria eligibility. Here, the principal investigator makes decisions based on factors they wish to control, such as a history of alcoholism, familial sudden death syndrome, or other medical conditions. Age can be an important concern and serve as a “rule-out.”

Of course, institutional review boards bear responsibility here, too. Questioning by board members regarding the reason for not including older patients is mandatory.

Every patient has the potential to bolster our knowledge and research base if we see past our bias. And what would a specific bias be in these cases? Are we selecting in only those who have many decades of life left and tossing aside those with possibly one decade of life left to them? How much is a decade of life worth these days?

The Ethos of Medical Ethics

Clinical research trials are essential for any headways to be made in the many wars medical science is currently engaged in worldwide for various diseases. It would stand to reason that these research trials would be comprised of individuals of all ages, ethnicities, and gender groups to ensure that we are utilizing a representative sample to come to valid results. But that doesn’t seem to be the case with two groups, particularly older adults and Black individuals.

Regarding Black individuals, we know a long history has contributed to a reluctance to engage in clinical trials. No one needs to tell us about the horrific trials in the South with Black men who thought they were being treated for a sexually transmitted disease (syphilis) when, in fact, they were being followed to catalog the progression of the disease and their deaths. They never received the medicine that would have cured them, penicillin.

Despite mandates by the federal government to ensure the inclusion of women and minorities in all federally funded research, African Americans continue to participate less frequently than Whites. Lower participation rates among African Americans have been reported across various study types (e.g., controlled clinical treatment trials, intervention trials, as well as studies on various disease conditions, including AIDS, Alzheimer’s disease, prostate cancer, and other malignancies, stroke, and cardiovascular disease).

Medical history must always keep that in the record books and understand the impact it has had on generations of Blacks. There are other examples of equally unethical research or experiments on this group.

Now, we face another difficulty or impediment, and that is in the area of age disparities in some clinical trials, but cancer is of utmost importance.

Cancer and the Aged Patient

Statistical census data released annually by major research entities indicate that 10% of those over the age of 65 have some form of cancer. The latest census figures for the United States suggest that there are over 65 million people in this age group, both male and female. Logically, this indicates almost seven million in that group have cancer.

Worldwide the World Health Organization indicates that each year 10 million people die from cancer worldwide, or one in six. In the US, in the 60–70-year-old group, cancer is the second most common cause of death.

The FDA has noted an underrepresentation of older adults in cancer-treatment trials. The National Cancer Institute’s data show decreasing enrollment in trials both FDA and SEER with advancing age. At ages 75 and greater, only 9% of research samples were in this age group. At 65, it was 36%.

By 2030, it is estimated that 70% of people over 65 will have some form of cancer. If that isn’t a compelling reason to begin enrolling this population into cancer clinical trials, I have to question the trials.

Arrogance and Ignorance in Research

I have to question the rationale for the trials, who is underwriting the trials, the background of the principal investigator in terms of ageism potential, and how significant the trials would be in a rapidly aging world. We cannot deny that the silver tsunami is upon us and will require billions of dollars of care for these patients.

If we do nothing or little to provide innovative, new treatments garnered from new research, we will find ourselves trying to swim without any floaties to support us.

One research paper indicated that if we fail to include this population in cancer clinical trials, there will be a lack of generalizability that can lead to challenges in treatment decisions for OA (older adults) and concerns regarding health inequity. Do older adults receive equal medical treatment today? I question that.

The editors indicated that trial structure, design, physician perspective, and patient or caregiver perspectives must be carefully evaluated and included as required. They call for actionable recommendations to address the challenges these types of cancer trials face, which may have been ignored in the past.

There is no room for ageism in clinical research, and when found, it must be addressed as strongly as possible because lives are on the line. To do less is extreme arrogance and ignorance in the face of what is coming down the road. No gods are working in medicine, and everyone must adhere to the strictest ethical guidelines possible and care for those who may have, either on purpose or thoughtlessly, fallen through the safety net.

Yes, I have heard chiefs of service refer to older patients as PIAs (no, it’s not Prolonged Infantile Apnea), a term which should have been erased from medicine many decades ago but is still held close in the minds of those who live in the past.