Clinical trials are designed to determine if new drugs, therapies, and medical devices are safe and effective for public use. These interventions are tested on diverse patient populations to gain important insights, but a new report from the International Longevity Centre (ILC) in the United Kingdom suggests greater diversity is needed –– especially when it comes to participants’ age.
Consider that 83.6% of people aged 60 to 75 take one or more prescription drugs. Yet a breakdown of trial participants published in the journal JAMA Network Open found that 50% of clinical trials specifically enroll patients under the age of 65, and only 8% of trials enroll patients 80 and older. Another study found that even when trials recruit older patients, they don’t recruit the ‘oldest’ in sufficient numbers.
While there are sometimes good reasons to limit elderly trial participants, older patients shouldn’t be excluded from clinical research altogether. With the global population of people aged 60 and older expected to double by 2050, now is the perfect time to increase trial recruitment efforts of seniors. Keep reading to learn why age diversity in clinical trials matters and how to improve your senior enrollment efforts.
Why Age Diversity In Clinical Trials Matters
Many drugs and therapeutics are designed to improve the lives of older adults, but people 60 and older are rarely represented in clinical trials.
This lack of age diversity is sometimes necessary. For instance, older people are more likely to experience adverse reactions. Moreover, seniors tend to have multiple health conditions, often requiring more clinical time and resources, which can cause costs to quickly add up.
Unfortunately, these guardrails can have unintended consequences. If a specific drug or therapeutic isn’t tested on all age groups, it may be less effective or more harmful to the demographics excluded. In this case, seniors.
The ILC report (mentioned above) encourages trial designers and other key decision-makers to develop recruitment protocols that include older people. By proactively engaging this segment of the population, it’s possible to gain better and more actionable research insights.
What Regulators Can Do To Increase Age Diversity in Clinical Trials
Currently, there isn’t a specific standard that addresses the challenges associated with recruiting older adults for clinical trials. In an effort to kickstart change, the ILC report outlines three steps regulators can take to enhance engagement with patients 60+ without being overly burdensome. These steps include:
Step 1: Update or Replace the International Council for Harmonisation (ICH) Guidelines
The original ICH Guidelines were drafted in 1993. While they outline recommendations for quality, safety, and efficacy, there are no similar suggestions for trial diversity. The authors of the ILC report say this needs to change. Specifically, they say all stakeholders should develop guidelines for including age diversity in trial cohorts.
Step 2: Incentivize funders and pharmaceutical organizations to invest in age diversity
The pros of increasing age diversity in trial cohorts greatly outweigh the cons, but many decision-makers don’t realize this. The authors of the ILC report say that now is the perfect time to start incentivizing funders and biopharmas to invest in age diversity.
With the global population rapidly aging, the need for solid scientific research conducted on older patients will only increase. By demonstrating that new drugs and therapeutics are both safe and effective for seniors, commercial opportunities abound. Highlighting a drug or therapeutics profit potential might seem cynical, but it’s an effective way to illustrate to businesses the opportunities that exist.
Step 3: Create a “Gold Standard” for Inclusive Trials
All clinical trials feature inclusion and exclusion criteria, but there isn’t a set standard across the board. The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched initiatives to highlight the importance of inclusive eligibility criteria, but barriers still remain, particularly when it comes to recruiting older adults.
The ILC report argues that establishing regulatory requirements for age diversity is key to success. Specifically, the authors note that “regulatory requirements must include diversity action plans that include all relevant protected characteristics and broaden the focus of existing diversity and inclusion (D&I) strategies to be more intersectional.” In other words, incorporating age considerations into your recruitment strategy will result in more inclusive research.
What Biopharmas Can Do To Increase Age Diversity in Clinical Trials
Regulators are responsible for making foundational changes to our industry, but biopharmas and medical device manufacturers can have a similarly large impact on age-related diversity recruitment efforts.
The ILC report encourages biopharmas to:
- Invest in tools that benefit older populations, such as wearable devices and remote monitoring technology
- Appoint diversity champions to prioritize anti-ageism in recruitment efforts
- Prioritize gathering age-related data in all clinical trials
- Gather and evaluate data regularly to ensure age diversity remains high on the agenda
Likewise, biopharmas and their research teams should expand their D&I initiatives to include age. Since it can be challenging to find older patients willing to enroll in a clinical trial, the ILC report suggests connecting with patient interest groups and/or focus groups that serve populations 60 and older.
Age Diversity in Clinical Trials – The Bottom Line
Clinical trial diversity has become increasingly important over the last decade, but there’s still plenty of room for improvement, particularly when it comes to senior citizens. With the global population of older adults rapidly increasing, there’s no better time to consider age diversity in your trial design and trial recruitment efforts.
Focusing on age diversity might seem daunting at first, but it’s easier than you think. The ILC’s report –– Trial and Error: Supporting Age Diversity in Clinical Trials –– provides actionable tips and advice. By adhering to these insights, policymakers, biopharmas, researchers, and medical practitioners can help create a future where quality research abounds and everyone thrives –– regardless of age.