The underrepresentation of older adults in clinical trials has drawn widespread attention across scientific and healthcare communities. Decentralized trials (DCTs) expand older adults’ access to trials, allowing them to participate at higher rates. Despite this opportunity, the industry hasn’t fully embraced the potential of Clinical Trials in Older Adults. One major challenge is a prevailing narrative that seniors cannot or will not adopt the technological tools needed for virtual trial participation.
However, a growing body of evidence shows seniors are defying these stereotypes. Successful studies indicate that older populations are not only receptive to virtual trials, but also highly engaged. These studies also reveal best practices for engaging seniors, which ultimately benefit sponsors and patients alike.
To better characterize older adults’ involvement in clinical trials, it’s important to note that the “senior” population is tremendously diverse in lifestyle, health status, engagement with healthcare providers and other factors that affect a clinical trial.
Furthermore, the process of aging affects people in different ways. The World Health Organization points out that “these changes are neither linear nor consistent, and they are only loosely associated with a person’s age in years. While some 70-year-olds enjoy extremely good health and functioning, other 70-year-olds are frail and require significant help from others.”
Despite the diversity among the senior population, the industry has often painted this age group with broad brushstrokes, with exclusion criteria that restrict adults ages 65 and up from participating. However, the data show several compelling reasons to revisit these limitations.
Seniors are the fastest-growing proportion of the global population, creating a demographic shift that researchers call a “silver tsunami.” By 2030, older people will outnumber children for the first time in history, and, according to the Census Bureau, 1 in 5 five Americans will be retirement age. With an aging population, the market for new treatment options will only continue to grow, requiring sponsors and clinical research organizations (CROs) to pay more attention to the needs of older adults.
The growing prominence of older adults makes demonstrating the safety and efficacy of new treatments indispensable. Older adults have an outsized burden of chronic diseases and consumption of prescription drugs. On average, older adults carry 60% of the national disease burden but represent only approximately 32% of participants in Phase II and III clinical trials. As a result, older adults are being overlooked in the development and validation of new drugs that will ultimately be destined for their use.
These gaps have implications for many different diseases. In the Journal of the National Cancer Institute, oncologists cited age-based disparities in cancer treatment, including “lack of evidence to inform delivery of personalized cancer care to elderly patients.” The research team noted that “Diagnostic and management strategies need to be extrapolated from data on younger patients, which is problematic because these would be empirically applied in a patient subgroup with different comorbidity profiles and, hence, unclear dosage requirements, drug response, and toxicity tolerance.”
The researchers concluded that “The primary contributor to this lack of data is underrepresentation or exclusion of older adults in cancer clinical trials despite most cancer occurrence peaking in the later decades of life. This evidence gap limits the potential benefits of new treatments for older patients and relegates treatment decisions to informed guesswork.”
Without adequate validation of drugs among older populations, patients are vulnerable to potential health risks that could otherwise be mitigated. As the oncology researchers noted, adverse effects associated with a drug can vary by the patient’s age: A 75-year-old may experience a different reaction than a 50-year-old.
Regulators have sent a clear message about the importance of recruiting a diverse population. The FDA has issued guidance encouraging inclusion in cancer clinical trials, and FDA officials have stated “Arbitrary upper age limits for trial entry are almost never justified.” As the population continues to age, regulators are likely to increase pressure on sponsors to prove they conducted adequate research to ensure safety and efficacy among older patients.
Sponsors also have economic reasons to consider the needs and preferences of older adults, who not only have higher incomes compared to younger cohorts but are also are the fastest-growing contributors to the consumer class. By 2030, seniors are projected to spend just under $15 trillion, up from $8.7 trillion in 2020, according to the World Data Lab.
Efficacy, safety, regulatory and economic factors all point to inclusion of the senior target population in a treatment’s clinical trials. However, with the exception of ‘geriatric’ studies, the industry has faced longstanding barriers to doing so.
Exclusion criteria around comorbidities and polypharmacy (using multiple drugs simultaneously) create concerns about adverse events unrelated to the trial product. Sponsors and CROs must take these conditions and medications into consideration, although a participant’s age doesn’t necessarily imply these concerns.
These barriers to inclusion are multifaceted and require significant cultural shifts in the industry. However, decentralized trials can help expand access for seniors, particularly those with limited mobility. Older adults are often hindered by a lack of transportation and limited access to clinical trials conducted at large urban centers. DCTs bring the trial directly to patients, which makes participation more convenient and allows sponsors to consider a much broader range of candidates.
Another barrier to inclusion has been the conventional wisdom that older adults are unwilling or unable to use technology—but the data tell a different story. In fact, age is not a major barrier to adopting new research technologies. AARP data show that:
· 77% of adults over 50 own a mobile device.
· Almost a third use their devices to manage or receive healthcare.
· 66 percent are comfortable sharing personal health information from wearable devices with health care providers.
1nHealth, a recruitment partner of ObvioHealth, has run three digital campaigns that recruited large elderly populations via social media and is preparing to conduct another large campaign. In a healthy older population study, a Facebook ad campaign from 1nHealth targeting adults 75+ resulted in over 30% of the qualified leads enrolling. And for a study seeking healthy older patients, 1nHealth saw engagement rates that were three times higher than average.
These indicators of high adoption send a strong signal that older adults are receptive to digital targeting. A recent clinical study from ObvioHealth bears out this finding. ObvioHealth was commissioned to assess the efficacy of an FDA-approved Class II medical device compared to standard exercises to treat stress urinary incontinence and stress-predominant mixed urinary incontinence in women. In just five months, 350 participants over age 18 enrolled, including 81 people ages 65 or older, representing 23% of participants. In that same study, women 65 and older complied with the study protocol at a much higher rate than younger women. The 65 and older cohort had a device adherence rate of 79 percent vs 59 percent in the younger population.
ObvioHealth partnered with 1nHealth to recruit patients for the trial. 1nHealth Marketing Director Daniel White noted that “Even when there's a wider range in age, we still see high engagement from seniors. The user group that yielded the most efficient results was age group 55-64. However, the group that yielded the most volume of results was age group 65+. We’ve also noticed that once a senior becomes interested in a study, they're much more likely to follow through and participate than a younger participant.”
In a separate study, ObvioHealth found that patients using their personal smartphones consistently completed their electronically patient-reported outcomes (ePRO) symptoms questionnaires at an overall compliance of more than 92%. The participant’s age did not affect the compliance rate, suggesting that mature participants are not dissuaded by the industry’s ever-growing use of technology.
To increase participation among seniors, sponsors and CROs can employ several best practices throughout the clinical trial journey:
Sponsors and CROs need to seek out seniors with targeted marketing campaigns. This strategy can pay dividends. “Seniors actually engage with ads at a higher rate than the general population,” 1nHealth marketing director Daniel White says. White offers several recommendations to increase engagement in digital campaigns:
· Choose the right platform. Facebook is generally a strong platform for reaching seniors. “Also, don't ignore Bing: It's the native search engine for PCs, and many seniors don't look for an alternative.”
· Clarify the message. “The ads that perform well are usually clear in messaging—for example, big text over photos translates well.”
· Rethink calls to action. “Sometimes best practices don't work: Engaging or uncommon calls to action typically work better than standard copy, but for one senior campaign we found the opposite to be true. The button to submit our pre-screening form says, ‘Find out if I qualify!’ and most digital marketers would agree this is preferable to ‘SUBMIT.’ For the older population, however, we hypothesized they were confused by the button text and expected to see ‘SUBMIT.’ When we changed the text, we noticed that the submission rate doubled.”
· Monitor campaign engagement. “Seniors often come back to the ad and post about their positive experiences. I personally monitored comments for a vitamin C real world evidence campaign and there were a lot of excited seniors commenting along the lines of, ‘I take Vitamin C, and it works great!’ because they want to engage with material they find compelling.”
Older adults may need accommodations, such as larger font sizes within a study questionnaire, to successfully complete in a virtual trial. However, intuitive, human-centered design should be at the forefront of every trial, not only those involving older adults. Sponsors and CROs need to anticipate and mitigate technology obstacles to maximize ease of use and increase compliance.
These considerations need to apply across devices. AARP notes device preferences vary among people of different ages: “Those under 50 are losing interest in tablets, for example, but those over 50 continue to buy them, with more than half owning one.”
Sponsors and CROs need to make sure study content is legible on screens of all sizes, and that information from validated questionnaires is presented in standardized formats to ensure accuracy. ObvioHealth factors these requirements into every study and continuously improves its app to increase user-friendliness. In fact, 88% of patients over 50 rated the ObvioHealth app as “very easy” to use.
Seniors need support, just like all participants in a trial—decentralized or not. A virtual study team helps provide the human touch points and tech support that participants need to succeed.
ObvioHealth’s virtual study team, known as the Clinical Oversight and Coordination Hub (COACH) team, has successfully engaged with seniors across several studies, using phone calls, texting and an online chat feature. In the recent urinary incontinence trial, the COACH team reached out to help participants prepare for the 4- and 8-week assessments, making sure they had the trial app open, so they received the notifications.
“Seniors have exceeded our expectations for tech-friendliness,” ObvioHealth medical director Dr. Parth Shah says. Shah suggests several ways to support seniors in a virtual trial:
· Inform them about the study design: The study team may need to educate participants around the concept of virtual activities rather than physical doctor’s visits.
· Be flexible with communication: Changing communication pathways can help clear up confusion. For example, some seniors may prefer to speak on the phone with study team members rather than chatting or texting.
· Treat patients with respect. In the end, working with seniors is not radically different from working with other humans. “I treat seniors as I would like to see my parents being treated: with kindness, respect, compassion and patience,” says Donna Guizado, a clinical trial specialist with ObvioHealth’s COACH team.
The value of including seniors in clinical research is hard to overstate, and decentralized trials offer an important step toward improving participation. By dismantling myths about tech adoption among seniors and proactively engaging seniors in every stage of clinical trials, sponsors and CROs can create a more inclusive research environment that improves safety, efficacy and delivers better business results.