I recently saw a request for clinical trial volunteers for a medication that might reduce my multiple sclerosis fatigue. “That’s great,” I thought. Fatigue is one of my worst MS symptoms. I’ve lived with it for decades and the Provigil (modafinil) that I’ve been using doesn’t help much anymore. This trial seemed like a natural for me.
But I didn’t have to read the participant requirements very far to reach a familiar barrier: age caps. The trial is limited to people with MS between 18 and 70 years old. I’m 75. I don’t make the cut.
That’s better than many other trials I’ve seen, though, some of which have age caps of only 50. For example, of the 6 clinical trials listed on the National Multiple Sclerosis Society’s website, and enrolling participants, 1 has an age limit of 65, 2 set 60 as the top age, and 3 don’t want anyone over 55. I can’t remember ever seeing a clinical trial that included someone my age.
Age caps are a serious problem
This lack of representation is not just a concern for seniors living with MS. A research letter published in the September 28, 2020 issue of JAMA Internal Medicine, during the height of the COVID-19 pandemic, reported that “older adults are likely to be excluded from more than 50% of COVID-19 clinical trials and 100% of vaccine trials. Such exclusion will limit the ability to evaluate the efficacy, dosage, and adverse effects of the intended treatments.” This was happening, the authors note, even though in the early stages of the pandemic, 80% of the people who died were older than 65.
Several years ago, an article in Perspectives in Clinical Research raised a red flag about this. The writers note that even though the elderly population is large, growing fast, and makes up the majority of users of the medications treating chronic illnesses, clinical trials typically cap their qualifying age at 64. Because of this, the authors believe, not enough is learned about how older patients respond to the medications that are being tested.
“Not all pharmacotherapeutic outcomes that can occur in the geriatric population can be predicted from nongeriatric populations,” they write. “Therefore, to assess the benefits and risks of a drug that will be used in elderly, these patients should be appropriately represented in clinical trials.”
Why limit trial participants?
An April, 2023 report from the International Longevity Centre (ILC), – a British think-tank devoted to finding ways for people to live longer, healthier and more fulfilling lives – cites several possible reasons for clinical trial age limits. Among them:
- Cost – Older participants can require more, costly vetting because they may carrier a greater risk of adverse effects.
- Data – Younger people may provide data that is less complex to study, since they probably have fewer coexisting illnesses or medications to consider.
- Personal burden – Older patients may have trouble traveling to a test location or may be burdened by treatment requirements.
There may also be arbitrary reasons. The report says, bluntly, “protocols may exclude certain groups (such as older people) disproportionately and without good reason.” (My emphasis.)
Including seniors in trials
The ILC report lists several reasons to include older people in clinical trials. Among them are that the effect of a medication is likely to vary depending on a patient’s age, i.e. one formulation may not fit all. Older patients may need treatments developed specifically for them.
The report also notes that many older people may be taking medications that will no longer improve their health outcomes. “Continuing to prescribe ineffective medicines is expensive; we believe that it’s an unnecessary drain on the resources of already-overstretched healthcare systems,” says the report. Not to mention draining the finances of patients who must pay for their treatments themselves.
Recommendations
Guidelines for improving age diversity in trial cohorts were written nearly 30 years ago. Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the ICH-E7 guidelines were published back in 1993.
The ILC report recommends regulators work with pharmaceutical companies and other stakeholders to co-produce new guidelines. That includes regulators creating incentives to boost investment in diverse trial cohorts and pharmaceutical companies creating “diversity champions” to push age diversity and prioritizing technology advances to benefit older people.
Do you think this sort of collaboration is likely, or even possible? Will more seniors be included in clinical trials?
One can only hope.
[Have you checked out my book, “The Multiple Sclerosis Toolbox“, yet?]
(A version of this post first appeared on the Rare Disease Advisor website.)
(Image by 00luvicecream from Pixabay)
