Patricia Jones, DrPH, MPH, MS, MBA, directs the Office of Special Populations at the National Institute on Aging (NIA), part of the National Institutes of Health (NIH). Generations Today spoke with her in mid-October for this issue on medical discoveries about how clinical trials work, and why there has been so little representation up to this point of BIPOC populations, especially older BIPOC, and how her organization is working to change that landscape. This Q&A has been edited for length.
Generations Today (GT): Why are clinical trials so important for medications and other health interventions?
Patricia Jones (PJ): Clinical trials are a very particular type of research. The big picture goal is to assess the effects of how an intervention, in a health-related or behavioral-related context, benefits [the potential user]. Clinical trials are very important because it’s a pathway to identifying new medications, new behavioral interventions and new therapies that can be brought to the marketplace and made available to people.
GT: How do scientists solicit participation in such trials?
PJ: Different research teams may use a variety of approaches to solicit participation. Some may use different strategies to solicit participation from different communities in a clinical or behavioral trial.
Strategies may include working with data scientists in their healthcare systems to identify health records of patients who may be potential candidates to invite to join their study. Researchers may reach out and invite them to learn more about the trial, explore the possibility of a particular trial and determine if they meet the eligibility criteria. Other researchers may use bus stop advertisements, TV commercials, print and newspaper ads, radio announcements and other resources like social media to make different groups aware of a trial.
Another way researchers might solicit participation in a trial is by either convening a community advisory group or a patient advisory group of caregivers, family members, patients or community members who have either been diagnosed with a condition and/or have the lived experience of accessing appropriate tests and diagnoses. [These groups] can help guide and inform where to advertise clinical trials open to enrollment, give feedback on the best way to describe and explain the purpose of the trial for a particular audience, and to help select images that might resonate or reflect the group of people the investigative team hopes to do a better job at engaging, recruiting and ultimately retaining in a trial.
GT: How often do older adults participate in clinical trials?
PJ: The rate of participation varies by different studies looking at different disease conditions and health issues. Cancer trials may have different rates of participation than diabetes or other types of clinical trials. Researchers looking at the inclusion of older adults reported in 2010 that in general older adults, who represent 60 percent of the national disease burden, actually represent only about 32 percent of participants who are enrolled in either a Phase II or Phase III clinical trial. A more recent publication reviewing the inclusion of older adults in vaccine clinical trials conducted over the past decade shows that among 170 trials reporting the participants’ age, 12 percent of participants were ages 65 or older, which is 4 percent lower than the U.S. population.
That disparity is important because Phase II and Phase III is where we really start to collect appreciable information and data that can help inform whether a particular treatment, drug or medication or behavioral strategy is working as intended (efficacy) and to further assess safety and effectiveness.
GT: Why has the number been low in the general population of older adults?
PJ: There a number of reasons. Some reasons may include the inclusion and exclusion criteria for clinical trials, which may be very specific and limit the types of individuals eligible to participate in a trial. Those rules can limit opportunities for older people who oftentimes may have more than one health condition or diagnosis. It is important for researchers to assess if the trial’s exclusion criteria are truly necessary and helpful to facilitate including the most diverse group of patients possible. Another reason is some healthcare providers do not inform some patients about different opportunities to join a trial.
GT: What is the NIA’s stance on including older adults in clinical trials, and what is the NIA doing to foster such inclusion?
PJ: The NIA has been a long-standing leader on promoting the NIH policy on the inclusion of women as well as minority underrepresented groups and older persons. Our leadership has been very visible and up front in leading workshops that have explored and actually changed policy that make it clear to investigators and researchers receiving NIH funding that every effort is expected to be made to better include people who are of Black, Brown and other racial/ethnic backgrounds, and women. The expectation from leadership at NIH has been very consistent and very clear over time.
A study reports that older adults represent 60 percent of the national disease burden, but only about 32 percent of participants enrolled in either a Phase II or Phase III clinical trial.
GT: How often are BIPOC older adults included in clinical trials? Can you talk about why, historically and currently, there may be reluctance on the part of this cohort to participate?
PJ: Challenges have long been with us and people have been very aware of underrepresented, under-included individuals in studies for a long time. Some reasons may include just lack of awareness and engagement. Researchers who are leading a study can make their colleagues and their peers aware and help influence their peers’ perception of who should be invited to consider participating in a trial. Oftentimes we don’t see that information being broadly shared with African American, Latino or Native American older adults.
The stringent inclusion criteria may make it an undue burden for including older persons that have more than one health condition. There are structural level factors that may influence general ideas around joining in clinical trials. And people are very much aware of historical examples of events that result in medical mistrust, like the Tuskegee experiment and Henrietta Lacks, but those are not necessarily the only factors that drive concerns among people today.
People are looking to see what the existing relationship between the entities requesting their help with a study and the communities they are asking to participate in a trial; they are interested in how entities have given back and invested in the very community where they want to do their research over time, or are they there simply for their own immediate gain and benefit.
Some are also interested in how information and lessons learned from clinical trials have been returned to their communities and they appreciate being made aware of how people of color are directly benefiting from the lessons learned and the extent to which research teams bring those details back and share the information in a meaningful way with the communities they invite or hope will volunteer. Long-standing relationships developed over time and returning information back to the study participants and communities, in general, can be important means of establishing trust and respect with the communities that we hope to see better included in clinical and behavioral trials.
GT: What is the NIA (especially the Office of Special Populations) doing to encourage participation in clinical trials from BIPOC older adults?
PJ: The NIA has recently adopted CROMS (Clinical Research Operations and Management System)—it’s one approach that may help research teams track their strategies and their success in engaging different participants in real-time, make reports and manage important study documents and relevant activities.
There are other tools, plans and documents that can guide research teams to be mindful of strategies to consider as they develop outreach plans, budget for outreach teams and support efforts that are available in the Alzheimer’s disease space and more broadly. There are also research tools available to NIA investigative teams to help craft messages that are specific and particularly attractive to certain racial or ethnic groups or to older adults.
GT: What should people who are considering participating in a clinical trial be aware of?
PJ: It’s always helpful to ask and engage your healthcare provider and make it known to them that you would like for them to share those details with you as they are made aware of them. There is a website at NIH that will allow people to identify available clinical trials, and local academic centers and universities in their area, oftentimes schools of public health or schools of medicine, that are leading or partnering with different entities to conduct clinical trials. They can seek opportunities through those resources as well.
Some research teams have identified trusted partners who have strong positive relationships with different segments of older communities of color. Those may include international sororities and fraternities, such as African American sororities and fraternities, faith-based organizations and other community partners. For those interested in volunteering or participating in a clinical trial they may look for resources and opportunities through those venues as well.
People want to see lessons learned in clinical trials brought back to the community and shared with the volunteers who participated in the trial.
GT: How has the COVID-19 pandemic changed older people’s participation in clinical trials?
PJ: COVID-19 has certainly served as a flashlight shining on a long-standing problem of disparate engagement, recruitment, retention and return of scientific evidence (all four parts) to African American, Latino, Native American and other communities of color. Ultimately, we see health disparities in COVID-19 as we have seen with other health conditions. It is very clear looking at the disparities with COVID-19 that the research enterprise, as a whole, lacked the structures that we needed to go forward and do a better job at engaging, recruiting and retaining study participants that reflect the diversity of our nation.
Through COVID-19, there have been opportunities to explore and research the hesitancies and concerns that people may have in participating in vaccine trials. That information elicited really great examples and resources to better inform other types of trials—where we want to engage similar groups of communities. We could learn lessons from vaccine trials and what we now know about vaccine concerns or reluctance. Unfortunately, it took COVID-19 to highlight what some people have known for quite some time. But I’m glad the conversation is afoot.
GT: What does the public tend to get wrong about clinical trials?
PJ: Clinical trials should include diverse study participants because they are intended to benefit the public, and the information gathered through clinical trials is intended to improve the quality of everyone’s life. If we have the opportunity to volunteer and participate in trials, that is a chance to provide rich, diverse information that better highlights a medication or a strategy in ways that may not be emphasized if we didn’t have a broad array of participants engaged. It’s really for the good of the public, and it’s helpful if the public does participate. However, we need healthcare providers and researchers to make patients and other groups aware of the opportunity to join a trial.
From the researcher perspective, it’s for the public good that we do everything we can to reach broadly, beyond our patients’ immediate circle of community members to engage as many people as we can and to revisit and rethink the parameters of who should be included and excluded so that we can collect a broad array of data and inform our studies as best as possible.
GT: What might be an ideal scenario for clinical trials going forward from a participant perspective?
PJ: The laudable goal that I have seen cited in at least one study is that 1 in 200 Americans enrolled in a particular study would be great, but we have quite a ways to go to establish a level of trust, authentic respect that really encourages participation and further build out a system that makes people aware, makes people comfortable and is inclusive of the different groups that make up our national fabric. Our fabric is diverse and so we need our study populations to be equally as diverse, consistently.
From the public perspective, clinical trial participation is just one approach to how people can make their perspective known. Research teams should engage patient and community members in different ways, in different roles, beyond as a participant; engage them as part of the research team that’s helping to plan your questions, plan your approach, plan your strategy for making people aware and for how you can turn your evidence back to the communities you hope will find your study attractive and of interest to them.
GT: And from a research perspective?
PJ: I would encourage teams to become more conversant and better informed on participatory research models that can be used. One example that has been adopted by researchers exploring different health conditions is the Community-based Participatory Model. However, there are other types of engagement models that could help inform approaches adopted by a team. Choosing a particular Participatory Action Research model can provide a process for diversifying their research team members and diversifying their approach on how they recruit members of their studies.
‘I’m looking at it from both ends of the spectrum, the composition of research staff who are on your team and how that reflects the study population’s diverse background.’
Another tool that might help researchers focus their intervention targets or identify study team members with different disciplines and backgrounds, as well as look at different levels of issues to analyze, is to use the NIA Health Disparities Framework. By using the NIA Health Disparities framework researchers might hire staff with backgrounds they may not have fully understood to be important or identify different levels for analyzing variables they otherwise would not have considered.
The goal is to broaden the researcher’s thinking on what factors drive health disparities; health disparities are oftentimes complex and stem from years of living with exposure to many different events that manifest as disease and illness as we progress over the life course. Having this broad understanding of what drives our health outcomes can impact the researcher’s understanding of what might improve a population’s health.
I’m looking at it from both ends of the spectrum, the composition of research staff who are on your team and how that reflects the study population’s diverse background—racial, ethnic, sexual/gender minority—whatever facets are really important and germane to the research question that you’re trying to answer with and for older persons; who are the research team members hired, who is making important administrative decisions about the trial, and who is communicating with study participants.
On the other end of the spectrum, the composition of your clinical trial study population; both ends of the spectrum benefit from the research team leadership adopting participatory action research models and approaches.
For more information about NIA tools and resources to support the conduct of clinical trials, see the following links:
- NIA’s clinical trials web portal—this is our main clinical trial page with a lot of information and other links, including:
- An overview of participating in dementia clinical trials.
- Infographic on participation in Alzheimer’s and related dementias clinical trials.
- This page links to a series of videos NIA developed that tell, in their own words, why study participants chose to join a clinical study.
- Azhleimers.gov—This is the federal government’s website/portal that links to multiple agencies’ information on dementia and Alzheimer’s disease. It includes information for people living with dementia, their caregivers and families, professionals, and includes a clinical trials finder.
- National Strategy for Recruitment in Alzheimer’s and Related Dementias Clinical Research—this is a strategy that NIA, in collaboration with several stakeholder groups and researchers, put together and released in 2018 that highlights the challenges and some strategies to engage a wider group of participants in AD clinical studies.