Age Diversity In Clinical Trials: Considerations For Improving Older Adult Representation

By Nick Charron and Hannah Yang, Clarkston Consulting

The share of the U.S. population aged 65 and older grew to 18% in 2024,¹ now outnumbering children in nearly half of the country's counties. These demographic shifts are expected to continue, with estimates stating that the global population above 60 will double by 2050.²

It’s crucial to understand how these trends impact clinical trials,³ where older adults have historically been underrepresented. For several large oncology indications, the enrollment-to-incidence ratio (EIR) is only 25% for those above 70,⁴ revealing a significant discrepancy in inclusion.

Without prioritizing DEI, research findings aren’t fully generalizable⁵ to this key demographic, limiting the applicability of trials. In this piece, we dive into the importance of age diversity in clinical trials, breaking down innovative methods to redesign clinical trials and better engage older populations in the U.S.

Implications Of Underrepresenting Older Adults In Clinical Trials

Despite the shifting demographics of the U.S. population, only 50%⁶ of clinical trials specifically enroll patients under the age of 65, and 8% of trials enroll patients 80 and older. Many clinical trials also exclude older adults with comorbidities,⁷ further limiting their relevance to real-world populations.

While it’s true that comorbidities can complicate trial results and risk jeopardizing approval of a viable therapy, overly stringent inclusion/exclusion (I/E) criteria unnecessarily restrict participation. This exclusion creates a gap in data⁸ on efficacy and safety of treatments for older patients, leaving healthcare providers without proper information for prescriptions.

With 88.6%⁹ of adults age 65 and older taking prescription medications, the consequences of underrepresentation are widespread. Older adults are more likely to experience adverse reactions, and those with multiple health conditions may need extra resources. Managing these risks can require more effort on the part of the principal investigator (PI), but striking a balance to ensure age diversity is critical.

Excluding older adults not only undermines generalizability but may also expose sponsors to greater AE/SAEs and associated costs, as older adults have shown incidence rates up to 1.5 times¹⁰ those of younger adults. For these reasons, it’s necessary to place DEI at the forefront of clinical trial design and recruitment to ensure that older adults can benefit from new medications.

Innovating Clinical Trial Design For Older Adults

To more accurately represent older adults in clinical trials, organizations must limit trial-related barriers by accommodating specific participant needs. This process begins by eliminating unnecessary eligibility criteria, but it’s also key to address transportation challenges and regulatory changes.

Decentralized Clinical Trials (DCTs)

Decentralized models¹¹ are one way for pharmaceutical companies to promote patient centricity by meeting older adults where they are. Home technology enables remote participation¹² with wearable devices and video conferences, both of which provide greater flexibility and ease of participation. Seventy-four percent¹³ of older adults prefer this option over going in-person to a clinic, demonstrating the need to be intentional about accommodating their lifestyles and habits. Frontier sites¹⁴ like local pharmacies and clinics in community accessible locations also can reduce transportation costs.

Though DCTs offer many potential benefits toward recruitment goals, they present operational and logistical challenges during implementation as well. Companies must ensure an adequate supply of medical equipment and secure digital infrastructure, in addition to coordinating models that align with both patient convenience and rigorous trial protocols. Additionally, new costs from technology platforms and regulatory compliance across varied jurisdictions present further hurdles. Companies should strategically balance these factors against retention efforts as they strive to expand access.

Evolving DEI Regulations

In addition to site selection considerations, regulatory shifts may present new guidelines for incorporating DEI into clinical trials. The 2022 Food and Drug Omnibus Reform Act (FDORA)¹⁵ mandated that the FDA release guidance on Diversity Action Plans (DAPs) for clinical trials. This will require sponsors to submit formal documents with enrollment goals and DEI strategies for Phase 3 and pivotal clinical trials.

The guidance was due to be finalized in June 2025, and Health Secretary Robert F. Kennedy Jr. stated¹⁶ that the process was still underway in January despite uncertainty surrounding recent executive orders. For organizations monitoring these changes, it’s ultimately important to plan ahead with DEI considerations before a trial begins to effectively reach diverse older populations.

Engaging Older Adults To Boost Participation

To build trust with older populations, organizations should provide support resources and clear marketing to encourage participation. Partnering with advocacy organizations¹⁷ like AARP can help educate patients and establish the reliability of the trial for those with limited digital access. Appointing specific individuals to champion diversity also can provide accountability for inclusion during recruitment efforts.

When it comes to recruitment strategies, older adults use different technology channels, so digital marketing tactics¹⁸ should cater to platforms they visit most often. Social media advertising on Facebook and email updates about ongoing trials can boost outreach efforts.

An additional factor to prioritize during outreach is engaging minority groups within older populations. Referral pathways to clinical trials for older patients still need improvement, especially for Black and Hispanic seniors. On a larger scale, there remains a historic mistrust of medical research among older adults in minority communities.

To restore openness, companies can consider community-based participatory research¹⁹ (CBPR) and similar methods that successfully built trust with younger populations. These practical strategies²⁰ can help older populations overcome barriers and engage in clinical trial participation.

Looking Ahead

As the U.S. population continues to age, the time is now to redesign clinical trials for inclusion of older adults. Proactive methods to reduce participation burden and build trust are essential to produce safe and effective medications. Organizations must go beyond regulatory compliance and take meaningful steps to promote DEI across the clinical trial life cycle.

References

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About The Authors:

Nick Charron is a consultant at Clarkston Consulting, serving clients in the life sciences, consumer products, and retail industries. His previous experience as a clinical research coordinator at Duke University and the University of Chicago focused on study design and management, process optimization, and regulatory compliance and guidance in clinical research. He holds an MBA and MSBA from Penn State University.

Hannah Yang is a sophomore at Duke University studying economics and sociology. Through her work at Clarkston, Yang has developed an interest in clinical trial trends and innovative models to improve accessibility. At Duke, Yang is involved in the Duke Consulting Club, Duke Association for Business Oriented Women, and the Backpack Project Durham.