Geriatric Drug Development Challenges and Strategies for Success

As global morbidity rates decline and the population continues to age, the presence of multimorbidities—defined as “the coexistence of two or more chronic conditions”—has become more common in geriatric patient populations. Providers across the industry, from clinical researchers to physicians, are acknowledging the importance of treating these multimorbidities, with geriatricians receiving additional training to care for these populations.

Key Highlights

As the global population continues to age, the need for geriatric and elderly participants in clinical trials increases. Read on to learn how drug developers are finding ways to include the elderly in research to provide better data and better efficacy for drugs.

PRA Health Sciences
PRA Health Sciences

In one 2013 study, the estimated prevalence of multimorbidity in the global population was more than 60%; among people age 85 and older, this estimate is upwards of 80%. By 2030, it’s estimated that 77 million people will be over 65 years of age. Recent survey results show that people between 62 and 85 years of age use more than five prescriptions concomitantly, and an additional 71.7% use these prescriptions along with over-the-counter drugs or supplements. Despite this, geriatric individuals—especially the oldest individuals in this category—are often excluded from clinical research “due to [the] perceived high risk associated with age, comorbidity, and polypharmacy.”

Challenges of Multimorbidity

A 2019 cross-sectional review published in the British Journal of Clinical Pharmacology found that only 62% of package inserts for drugs approved by the United States Food and Drug Administration (FDA) included pharmacokinetic reports on the drug’s use in elderly patients, while only 42% and 45%, respectively, included safety and efficacy data for this population. Only data regarding pharmacokinetic information has increased appreciably over time—“crucial” safety and efficacy data are still, according to study authors, insufficient.

Medical literature shows that there’s underrepresentation of geriatric patients in clinical trials—yet, elderly and geriatric populations both carry the highest chronic disease burden and “consume the majority of prescribed medications.”

The need for drug development for elderly populations is significant, particularly in the face of data showing how many prescriptions geriatric patients take daily. But despite this, the “geriatric gap” persists.

According to the authors of a study published in Circulation, one major issue in clinical research is the use of exclusion criteria that “disproportionately” excludes older adults, including decreased life expectancy, functional limitations, cognitive impairment, the presence of serious concomitant illnesses, or residency in a nursing home. The authors also point out that clinical research is notorious in its underrepresentation of women—who often make up the majority of older cohorts.

One response from the clinical research community has been to eliminate age-based exclusions and the use of exclusion criteria that would limit the participation of geriatric adults. However, as the authors of the study point out, the healthcare community has been slow to enact the “systematic effort necessary to ensure representation of older adults in pivotal research.”

Another challenge of geriatric inclusion is that the populations of patients who are ultimately enrolled are often biased and do not provide data generalizable to a wider population of geriatric individuals. Volunteer participants in trials—especially for trials that require numerous site visits or high participant involvement—tend to skew toward “healthier” individuals, leaving behind the patients who may ultimately end up needing the intervention in question the most.

One outcome of excluding elderly patients, and, further, more sick elderly patients, is inaccurate data on adverse drug reactions. According to the British Journal of Clinical Pharmacology, claims are often made that adverse drug reactions are “more frequent” in elderly populations. Still, many of these claims are based on inadequate drug usage data. These claims, according to the authors, also don’t take into account the role that other factors like polypharmacy or renal dysfunction play in generating adverse drug reactions. This “bad” data may result in geriatric patients not receiving necessary treatment and ultimately resulting in patient harm.

Can Decentralized Trials Help?

Despite these challenges, change may be on the horizon. In September 2020, the FDA released a draft guidance statement for the industry providing product labeling guidance for geriatric populations. One key aspect of this statement is the guidance that sponsors not consider geriatric patients as one homogenous group of individuals—differences in organ function, comorbidities, concomitant drug use, and drug distribution and elimination should all be considered, and use statements should categorize patients into smaller subgroups based on age (ie, ages 65-74, 75-84, and 85+) due to the differences in patient response.

Learn more about the digital technologies used in DCTs

Decentralized clinical trials (DCTs) may also represent an avenue to include more geriatric patients in clinical research—particularly patients who have mobility issues or for whom the presence of multimorbidities makes it challenging to attend multiple site visits. And as with all decentralized research, decentralized clinical trials will allow researchers to gather data from a more geographically diverse group of patients, ultimately—and hopefully—increasing the generalizability of results.

Decentralized trials, though, come with their own potential set of issues: the reliance on technology in the form of telehealth, mobile app-based monitoring, and other electronic data collection methods may create a barrier for potential participants who are less tech-savvy than their younger counterparts.

However, the benefits of decentralized clinical trials may far outweigh these concerns—mainly because many decentralized clinical trials still rely on visits from local healthcare providers who could be trained, prior to the trial’s start, in educating participants about the digital technology at play. A more positive patient experience—including a reduced or eliminated burden of travel—is a trade-off worth making when designing decentralized clinical trials for populations of geriatric adults since increased participation would lead to more, and better, safety and efficacy data.

Developing clinical research for geriatric patients can be challenging, but the effort is worthwhile when patient safety is on the line. Although sponsors must consider the role that multimorbidities play in the data collected, the presence of alone is not a good reason to exclude a population that bears the highest burden of chronic disease from research, and learning how to work with these patients will lead to better—and more patient-centered—clinical trial results.

Improved participant access to clinical trials means more patient diversity. The ability to connect to a broader population increases the quality of clinical drug development. Our ability to combine medical informatics with the augmented intelligence of our word-class data scientists allow us to track, interpret, and predict what works for unique and diverse patient populations. DCTs allow us to meet patients where they are—regardless of race, gender, socioeconomic status, or ethnicity.

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