A conversation with Emma Thorp, chief commercial officer at RBW, and Esther McNamara, senior health policy lead at ILC
Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults. According to the report, older people are prescribed more medications more frequently than other age groups. Yet, they are consistently underrepresented in the trials testing the safety and efficacy of medicines. This lack of age diversity in clinical trials has serious implications for the health and well-being of older patients, as well as for the validity and generalizability of trial results.
The report, titled Trial and Error, urges regulators, pharmaceutical companies, and researchers to prioritize age diversity at all stages of the clinical trial process. Although some progress has been made in recruiting older participants for clinical trials, the report suggests that these efforts do not match the scale of the problem.
To ILC: What did you base the findings of the report on, and what barriers did it identify?
MCNAMARA: The ILC based its findings on in-depth expert interviews and a roundtable discussion, which identified several barriers to age parity in trial design. One of the most significant barriers is the prohibitive cost of recruiting older participants, who may have more health conditions and require more clinical time and resources. The report argues that this cost should be viewed as an investment in public health, given the increased demand for medications among older individuals. Pharmaceutical companies, in particular, have an incentive to prioritize age in trial cohorts. As demographic change continues to affect societies, they will have more older consumers to whom they can market their medicines.
Another barrier identified by the report is the arbitrary exclusion of older participants in clinical trial protocols. This exclusion can be direct, with age-specific criteria for enrollment, or indirect, with decisions made by the trial team to exclude age-diverse cohorts. This arbitrary exclusion can lead to the development of medications that are less effective or harmful to older individuals, who are more likely to have comorbidities and experience drug-drug interactions. The ILC report suggests that clinical trial protocols should be designed to include older individuals and that trial teams should be proactive in recruiting age-diverse cohorts.
To ILC: The report provides practical recommendations for improving age diversity in clinical trials. What are some of the highlights, and how could they be taken forward in practice?
MCNAMARA: One of the recommendations is to collect age-related data across all trials, particularly those testing medications for conditions not associated with aging. This data could help to identify where older patients’ participation is lacking and which trials successfully include significant numbers of older people. Another recommendation is to increase awareness of the importance of including older individuals in clinical trial design. This could be achieved through educational programs for pharmaceutical companies, regulators, and researchers, as well as public engagement campaigns to raise awareness of the benefits of age diversity in clinical trials.
TO ILC: The report is released following a number of legislative and statutory changes. Why is this timing important?
MCNAMARA: The report comes at a time when the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has announced a series of legislative changes designed to streamline clinical trial applications. Guidance will accompany this change in legislation, outlining how trials can “include patients meaningfully into the design and conduct of trials” and “achieve diversity in trials in a way that is proportionate and achieves the best results.”
As of February 2023, the U.S. has a statutory requirement that applications for late-stage approval of clinical trials submitted to the FDA must include diversity action plans. The plans must describe the funder’s/researcher’s goals for increasing enrollment from underrepresented groups and explain how these goals will be achieved. The primary focus is currently on racial and ethnic diversity, which is sorely needed to address the long-standing inequality of access and care for non-white patients. Increasing the scope of these initiatives to be more intersectional in terms of age and other characteristics would be extremely beneficial for cohorts that are truly diverse on several indicators.
Such initiatives in the U.S. and elsewhere are timely, but we urgently need guidelines for clinical trials to put age diversity on a par with gender and ethnicity. The ILC makes recommendations in this report that affect stakeholders at all stages of the trial process. Only once these changes have been made will clinical trials generate the evidence that older patients deserve when they are prescribed medicines.
To RBW: Why did RBW Consulting decide to partner up with ILC and take part in this project?
THORP: RBW always has been proud of our role in helping companies deliver better health and well-being outcomes for patients, and we take our responsibility to find world-class talent for the innovative and essential life sciences sector seriously. That means us not just servicing the sector but operating as true partners. In line with our B Corp-led philosophy, we decided we wanted to take that commitment even further with a new program that would see us going way beyond our core role as a recruitment company.
RBW are proud to have partnered with the ILC on this important work. Against the backdrop of the United Nations’ decade of healthy aging, it felt like the right time to drill down into the needs of older people as part of the movement to make clinical trials more representative.
It is RBW’s second initiative under its innovative IMPACT program, which sees the consultancy invest pro bono in patient-focused projects where there is a shortage of knowledge, data, discussion, or practical implementation on important issues within the health or life sciences sectors.
To RBW: Why is underrepresenting older people in clinical trials a problem?
THORP: Older adults are a significant and growing segment of the population, and they are disproportionately affected by many of the chronic and age-related conditions that new treatments aim to address. However, despite this fact, older adults are often underrepresented in clinical trials. This is a problem because clinical trial results may not be generalizable to older patients if older adults are not well-represented in the study population. It is estimated that between two and nine medications are taken every day by older people across different countries and populations. A 2014 study found that one-third of trials excluded people purely on the basis of age; another study in the U.S. from 2022 found that trials that were inclusive of older adults still did not recruit the “oldest old” in sufficient numbers. Some steps have been taken in the right direction since then, and recent developments in remote and flexible trial designs have made participation more accessible than ever. Yet action is required across the board to ensure that older patients are able to leverage this increased accessibility. The ILC’s report emphasizes that we need structural and cultural change to ensure that the people who use medications and treatments are adequately represented in the trial process.
To RBW: What do you hope this report will achieve?
THORP: This is a topic that affects so many people inside our industry and beyond. We hope this report provides a platform for people in the industry to work toward inclusive trial design. Don’t be afraid to ask questions about the topic or share the recommendations — the more we’re able to discuss and promote practical solutions, the more progress we’ll make. It is our hope that this work will support others’ devoted efforts to bring about meaningful change.
In Summary: The “Trial and Error” recommendations
The report recommends that regulators:
- co-produce new guidelines to update and replace the 1993 International Council for Harmonisation (ICH) guidelines, which do not address current trial diversity challenges. New guidelines should be developed by all stakeholders and clearly specify requirements for facilitating age diversity in trial cohorts. These actions and targets should be ambitious without being overly burdensome.
- incentivize increased investment in trial cohort age diversity and emphasize that it’s in the best commercial interests of funders and pharmaceutical organizations to demonstrate that their products are effective for older patients, as these markets continue to increase and
- create a gold standard for inclusive trials.
While pharmaceutical organizations:
- prioritize gathering age-related data throughout all trials,
- appoint diversity champions to prioritize anti-ageism,
- employ diversity champions to gather data and build a more comprehensive picture of what works for different groups of older people,
- gather and evaluate this data to ensure that age diversity is high on the agenda, and
- invest in technological advances for the benefit of older populations.
The report further recommends that researchers:
- expand diversity and inclusion (D&I) initiatives to include age and other characteristics and
- consider the intersection of all the characteristics that are medically and socially relevant to trial outcomes, including but not limited to age, socioeconomic status, disability, gender identity, and sexual orientation.
Regulators and pharmaceutical companies should work together to devise a method of classifying the trials that prioritize age diversity in their design, recruitment, and delivery, to earn the trust of prescribing clinicians and patients. Only the trials that go above and beyond to incorporate intersectionality into their diversity and inclusion strategies would be eligible to be badged as “gold standard” by regulators.
The report recommends that each pharmaceutical organization should appoint a named diversity champion who:
- champions age as an important characteristic,
- facilitates trial researchers undertaking meaningful engagement with trial participants and the wider public, including focus groups, networks/links with underserved community groups, or engagement with other patient interest groups,
- advocates for post-marketing data collection in cases where insufficient numbers of older people were included in the trial, and
- works in collaboration with the research leads effectively explain the results of the trial and disseminate that information to participants, interested communities, and patient and public improvement (PPI) groups.
Finally, the report recommends funders and institutions:
- set aside resources to develop consistent PPI infrastructure,
- create permanent networks of patients, carers, and other community members for trial researchers to consult at every stage to ensure that their trials are accessible and workable for older participants, and
- co-produce agendas and trial strategies with PPI groups wherever possible to increase trust and participation and help to identify potential issues and barriers in trials before they arise.
You can read the full report on ILC’s website.
About The Experts:
Emma Thorp is chief commercial officer at RBW Consulting, a life science recruitment and search consultancy. Emma has worked in the life science sector for many years and is deeply networked across the whole life science ecosystem within Europe and North America. Emma is the lead for RBW’s IMPACT programs as well as overseeing the development and management of key client relationships.
Esther McNamara joined the International Longevity Centre (ILC), the leading think tank on the impact of longevity on society, in November 2022 as senior health policy lead. She led the ILC’s work on the Trial and Error project.