Older adults left out of clinical research trials

Although they experience more health issues, older patients often aren’t included in research due to age and underlying medical conditions

2:10 PM

Author | Valerie Goodwin

physician talking to patient with lab researcher in background
Credit: Jacob Dwyer, Michigan Medicine

Adults aged 65 and older account for one in six people in the United States.

As the older adult population increases, it’s important to recognize there’s a lack of age-specific guidelines for the delivery of high quality care.

Older adults are often excluded from research based on age alone, or for having other health complications they may be experiencing in addition to what’s being studied.

“A third of clinical trials funded by the NIH between 1965 to 2015 had arbitrary upper age limits without a clear explanation,” said Jiha Lee, M.D., M.S., an assistant professor of rheumatology at the University of Michigan, who works closely with many older individuals with rheumatic diseases.

Including older adults in research can be beneficial, though, says Lee.

Not only do older adults have different needs for care, but they also have different goals when it comes to treatment.

Research inclusion

“Many researchers seek data that allows the study of a single condition of interest, however, in reality, the majority of adults over the age of 65 have two or more medical conditions which limits the generalizability and application of research findings in usual care,” said Lee.

“The various health complications and multiple medications that older adults live with in their day to day can affect results which may deter many researchers from having them participate in clinical trials when in actuality it is vital that older adults are involved in research.”

Including older patients in research can give insight into how different medications and treatments work for patients of all ages as well as how these treatments interact with other common medical conditions among older adults.

This increase in information can help providers better care for older adults by understanding how different treatments will impact this demographic.

Including older adults in research also helps researchers understand the goals older adults have that may be different from those of in younger individuals.

“In rheumatology, when conducting research or treating patients, we are looking to see if the medication or treatment will lower the disease activity or bring remission in the patient with rheumatic diseases,” said Lee.

“For many older adults, intense treatment that eradicates their disease but potentially makes them feel worse or experience side effects is not necessarily their main goal.”

Sometimes the goal is just being able to comfortably move around the house or be with loved ones,” Lee says.

When it comes to collecting data from older adults in research groups, there can be accessibility issues faced by both the researcher and the participant.

Common accessibility issues include transportation, comfortability, and communication methods.

“Similar to pediatric researchers, we need to find a way to collect information that is meaningful to older adults in a way that is not cumbersome or burdensome,” said Lee.

“Making sure that the participant is comfortable with the way they are reporting data is crucial to making sure that data collection is successful. We need to think about how to address these barriers to better recruit older adults and then care for them throughout the process so that their participation is a positive experience and valued.”

Older adults in research may hold the key

For older adults, their importance in research is now being noticed on a national level.

Strides are being taken to make sure that older adults are represented in research to improve their care in years to come.

The NIH Inclusion Across Lifespan Policy states that individuals of all ages must be included in all human subjects research.

The National Institute on Aging is at the forefront of ensuring that this policy is upheld and announced they will give priority to studies that include more older adults into research in the coming years.

The geriatric community has created frameworks to help approach the unique needs and complexity when caring for older adults, as well as to facilitate their participation in research.

These frameworks are known as the five Ms (medication, mobility, multicomplexity, mind and what matters most) and the five Ts (target population, team, time, tips to accommodate and tools.)

These categories encourage researchers to consider ways they can identify and address the needs of older adult participants to gather the best data possible by considering the complex daily lives of their participants.

Having older adults share their experience participating in research trials is also beneficial to adjusting the research process.

The feedback researchers collect about how older adult participants felt during the study can pave the way for better data collection processes in the future.

Participant feedback could help tools, such as the five Ms and five Ts, become more effective over time.

“Older individuals should know that they play a vital role in bringing valuable insight to research,” said Lee.

“Their participation in research is not only welcome but needed to better understand how to serve our aging population. Without their participation, it will be challenging to make significant advances in the care of older adults.”

Lee encourages older adults to talk to their provider about research opportunities they can become involved in or investigate opportunities on their own using UMHealthResearch.org.


More Articles About: Geriatrics All Research Topics Mental Health Community Health
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