The beginning of October recognizes The International Day of Older Persons, a day dedicated to raising awareness about health concerns and issues surrounding older persons. It is also a time to reflect on the contributions that older people make to society.
For International Day of Older Persons 2020, we spoke with two of our PRA Health Sciences experts about improving awareness efforts and clinical development solutions for the health and lifestyles of older populations.
In light of the International Day of Older Persons, we spoke with two of our PRA Health Sciences experts about improving awareness efforts and clinical development solutions for the health and lifestyles of older populations.
This article was written with contributions from the following experts:
- Heather Jordan, Medical Director, Medical Affairs
- Mark Lane, Executive Director, Global Drug Development
Tell us about your experience and expertise regarding drug development for older persons, and indeed PRA's experience and expertise in that area.
HJ: I'm involved in Early Development Studies at PRA, which includes renal and hepatic impairment studies. These studies help to identify if drug dosages will require adjustments in persons with renal and hepatic function abnormalities. The studies also will subsequently help to inform dosing in aging populations.
I'm also involved in a study right now that targets healthy elderly volunteers. With most of our early development studies, we tend to recruit a healthy population under age 65. It’s interesting to be involved in a study that looks at a healthy elderly population.
In the past five years, PRA has participated in 100+ clinical studies and non-clinical projects targeting 21,000+ patients and healthy volunteers at 3,900 sites globally. We’ve participated in multiple studies requiring age-related disease experience, such as acute renal failure, Alzheimer's disease, Chronic obstructive pulmonary disease (COPD), Huntington's disease, Osteoarthritis, and Parkinson's disease.
ML: My expertise in aging is based in the biology of aging. Prior to joining the pharmaceutical industry, I was at the National Institute on Aging. I led a group there studying aging in primates and other models, mostly focused on nutritional aspects of aging.
We possess significant experience with clinical trials where we include older individuals, particularly in areas like Alzheimer's, which is a significant risk for older populations .
Currently, the primary focus of drug development is for treating diseases that affect aging populations, not treating aging itself. There are 35-year-olds that need the same class of medications to treat their heart disease as 85-year-olds. The etiology of the cause may be different—it may not be aging itself. There needs to be a big mindset shift away from treating only the chronic disease to treating aging that is associated with a higher incidence of chronic disease. That's a challenge both for regulators as well as drug developers.
A significant contributor in the efforts to address the health needs of the elderly is PRA’s Mobile Health Platform and associated data and technologies. Those facets can help with participation in clinical trials, or even just help in requesting assistance from a pharmacist or doctor when you can no longer drive. For example, you can have virtual visits over the phone or you can record your blood pressure or a glucose reading via remote wearable devices. Through some of our mobile technologies, we can send those results to your doctor or your investigator in a trial.
What awareness efforts exist to educate the public on the special health needs of older persons? How can we improve awareness?
HJ: The World Health Organization (WHO) has declared 2020-2030 the decade of healthy aging. They define healthy aging as “the process of developing and maintaining the functional ability that enables wellbeing at an older age. Functional ability is about having the capabilities that enable all people to be and do what they have reason to value.”
There are multiple organizations that promote awareness about older persons, such as the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the National Institute of Aging, and even AARP. Plus, there are numerous disease-specific organizations that promote older persons within their disease focus.
ML: Unfortunately, while there are groups that advocate for and promote awareness of the multiple challenges facing our aging population, there are few that focus specifically on the special health needs of older persons. For example, there are many conditions associated with aging, such as hearing loss, cataracts, osteoarthritis, cardiovascular disease, COPD, and diabetes. Many older persons are likely to suffer from several of these at the same time. While these and other conditions are recognized as being associated with aging, we don't view them as special health needs necessarily with that population.
The WHO is considering a new framework, which proposes the classification of aging as a condition in all organs, along with the comprehensive classification of all aging-related diseases. This will notionally drive resources towards unmet needs and improve drug development and use.
Recently, a team of international experts released a call-to-action to consider revising the International Classification of Diseases (ICD-11). In its current form, the document lists “old age” under the “general symptoms” classification. While aging is commonly classed as a condition only in relation to skin aging, that leaves the rest of the body unaccounted for. The call-to-action suggests a framework for classifying age-related diseases, their level of severity, and extending this classification to the tissue and organ level. This means aging in the liver, for instance, would be given its own stage and classification code.
Are there any current developments that would allow older persons to easily contribute to their own health and functions?
HJ: We know that older persons tend to use electronic tools less frequently than those in other age groups. There has been some research designed to explore how to support older persons to become more digitally literate—from playing with tablets to actual instruction on certain software. A critical part of these studies is making sure that patient portals, where people can establish a more direct link to care providers and personal health records, are user-friendly and easy-to-follow.
Telehealth has also become an important part of medical care during the pandemic, and is especially beneficial for an older population who may have transportation or mobility challenges.Having a digital option is helpful to support a digital waiting room for the older patient, especially if there's a team care model in place.
ML: While not a new development, exercise is important. Exercise when you're 70 means something different than exercise when you're 30, so you’d want to seek your doctor's advice. But regardless, staying physically active and staying mentally active is crucial.
Since my father spent so much of his life working, he didn’t want to do anything in his retirement. He didn't join a book club or a walking group. He had no interest in participating in the structured activities that can bring more joy and meaning to older populations. I truly think that accelerated his decline.
Those same principles could be applied to the use of technology, as well. Part of staying active and mentally sharp is keeping up with changing technology. There are apps that can help you “train your brain” to help fight cognitive decline with aging. Research has shown time and time again that keeping your mind and body active can extend the period of healthy aging.
How is the pandemic disproportionately affecting older persons and their access to care?
HJ: There was a dramatic decrease in the number of in-person medical visits in the late winter to early spring of this past year. Older persons in particular delayed health care for acute and chronic illnesses, as well as preventive screenings.
Outpatient care shifted mostly to telehealth and some elderly patients really struggled with this technology. Medical staff phone calls to older patients in advance of the visit to prepare them helped telehealth visits be more successful. Even more useful is the use of video calls, as people feel more of a connection than with an audio phone call. It’s critical to help support those elderly patients as they get used to this new telehealth environment.
I think what also came to the forefront during the pandemic was knowing that older persons deal with loneliness and feelings of isolation, just as all of us do. With the quarantines and limited social interactions during COVID-19, wellbeing worsened in elderly patients, especially those with mental health issues at baseline. Telehealth is certainly important for regular chronic diseases, but it can be incredibly useful for treating mental health as well.
In addition, the pandemic brought a lot of attention to nursing homes and infection control processes within them. All visits to nursing homes were restricted back in March. They were locked down to try to contain the virus. In mid-September 2020, the Center for Medicare and Medicaid Services (CMS) released updated guidelines on how visits can be done safely in nursing homes. They strongly suggest outdoor visits as a way to facilitate social distancing. These guidelines offer solutions that greatly improve older persons’ social connectedness in this time of isolation.
ML: It’s a well-known fact that older individuals, particularly those with pre-existing conditions, are more susceptible to the ravaging impacts of the pandemic.
Some of that is related to the changes in the immune system and other body functions that occur with age, which are not easy to address. It helps to explain why someone who's 75 or 80 years old without significant pre-existing conditions may be impacted more by the infection, versus how a 30-year-old may be impacted.
Of course, that’s just on average. There are cases of a 30-year-old that didn't fare well and an 80-year-old that recovered with minimal difficulty. Yet the changes that occur with aging on a number of the body systems, even if you're not classified as having a chronic disease, can make you somewhat more susceptible to the effects of coronavirus.
What can those involved in healthcare and life sciences do to properly address the health of older persons, in this pandemic and for the future?
HJ: Needs of older persons will differ by community and require a tailored response. Listening to what older persons have to say and valuing their voices will help shape necessary support services. If we know what’s important to those older persons, and we know what their needs are, then we can be prepared to respond appropriately.
We also should work with older persons to help them develop increased comfort levels with technology. I think that COVID-19 has brought telehealth into the spotlight. It's not going to fade away as the pandemic resolves. Telehealth visits are now a critical piece of healthcare, especially for elderly persons who have difficulty leaving their homes and using transportation. We need to focus on a a flexible approach to meet the elderly community where they're at.
ML: If you look at the socioeconomic status of the aging population, some people will have higher income and others will have lower incomes. An example of how this impacts the health of the elderly is pill splitting. Because they may have difficulty affording their treatment, they may cut the pill in half or reduce the frequency of dosing which compromises outcomes. Another important factor to consider is the pharmacokinetics or the metabolism of drugs. For example, these are changes in hydration, fat content and distribution or the ability to chew or swallow. Combined with changes in organ function as we age, this could impact how drugs are metabolized. So, the pharmacokinetics of a drug that you study in a 30-year-old is not necessarily going to be the same in somebody who's 80 years old. It requires more thought, studying, and understanding of the drugs’ metabolism and how you can adjust for that in an elderly population.
Another consideration is that older persons tend to have trouble swallowing or may not be able to self-administer certain types of drugs. How do we ensure that the drug that's being developed is going to be metabolized correctly? How do you ensure that the required dose is delivered in a consistent and compliant manner?
In addition, those on a fixed income may not be able to participate in clinical trials because it requires technology or transportation that is difficult for them. There needs to be someone to assist that older individual with understanding technology or offering transportation to visit their doctor or get to a clinical trial site.
Generally speaking, drug development does not tend to target older persons as the primary or only patient population— they’re instead a subset of a larger population for which the drug is being developed. I think we could do a lot for drug development if we tried to include more older persons in our clinical trials, where appropriate. Cardiovascular disease is a good example. It’s one of the main causes of death globally and well over half the people with cardiovascular disease are over the age of 65. But when you look at the participants in clinical trials, older persons make up less than half of the participants in the clinical trial for this area.
How can we reduce health disparities between older persons/younger persons and older persons in higher income vs. lower income countries?
HJ: Over the years, there's been a lot more focus on the social determinants of health. The Agency for Healthcare Research and Quality issues an annual report on national healthcare quality and disparities.
There's certainly more work to do, but I think the best that people can do is to know their community resources and how to engage with them. For example, social workers can help especially if integrated into a physician’s clinic. There are also online resources that list agencies for assistance and how they can be accessed.
ML: In general, access to healthcare is a significant challenge in high-income versus low-income countries. For example, access to and affordability of medication, access to more sophisticated diagnostic equipment, specialty care, technology and clinical trials will certainly be exacerbated in the elderly populations of low income countries.
The traditional approach to clinical development requires 100% of visits to take place on-site, which places a huge burden on patients. We’re working on increasing access to care for elderly populations via technology-enabled clinical trials that allow them to participate from the comfort of their own homes.
We support the phase II-III clinical development of niche treatments, blockbuster drugs, and biosimilars that help save lives.
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