When we think about diversity and clinical trials, we must be honest in our assessment that we are not there yet. This is not a new problem, as decades of reports codify disparities in healthcare research outcomes. Nor is this a problem that has been ignored completely. There have been many efforts to understand and address those factors believed to interfere with our ability to include diverse participants in clinical trials.
So, we should ask the question, “Why do we continue to miss the mark of full participation in clinical research of diverse communities?” I believe we are on the road to more inclusive research, but we haven’t arrived yet.
If our goal is full participation in clinical research of diverse communities, how are we doing? We can compare data from a 2020 snapshot of global clinical trial participants with the 2021 US Census data. While this is not a direct comparison, given the discrepancy between global and US data, a closer look at the data provides some important context.
The snapshot reveals that 56% of clinical trial participants in 2020 were female. That’s a great start. The ethnic and racial makeup for trial participants was 75% white, while whites comprise 59.3% of the US population in the Census data. Only 8% of the trial participants were Black, though Blacks make up 12.6% of the US population. And the Asian trial cohort came in at 6%, whereas people of Asian descent make up 4.9% of the US population. Finally, the Hispanic population accounted for 11% of trial participants but makes up 18.9% of the US population. These data tell us that we are making progress toward inclusion, but there is work to be done.
We know the barriers to full inclusion in clinical trials are many and varied but let me touch on just a few to set the stage for some of the work that needs to be done.
Protocol Design Impacts Access
In promoting appropriate patient participation, those who are designing clinical trials need to be aware of the following important factors:
- Fuller understanding of the epidemiology of the condition being studied
- How trial inclusion and exclusion criteria might affect who can participate
- Real-world conditions, such as location of trial site, travel requirements, number of visits and procedures, time spent at site for visit, and more
Clinical trials are designed to assess the safety and efficacy of a new intervention, but their effectiveness in real-world conditions must also be considered. Historically, clinical trials have missed the mark in recruiting patients from underserved populations that the treatment might eventually help. Researchers must do their homework and understand the prevalence of the disease or condition, and the patient communities that it may disproportionately or differentially affect. They should be asking themselves, “How should these factors play into how I approach patient recruitment?”
The trial’s inclusion and exclusion criteria can be another place where certain communities may be inadvertently excluded. To give an example, there may be a criterion around a certain laboratory value for which we have a standard ‘normal’ range. However, we know that certain racial or ethnic populations have recognized variations in ‘normal’ values. Understanding and accommodating for these differences is critical. If researchers are not aware or do not include such adjustments, then some groups of patients may be excluded. This can be true not only for laboratory values, but also imaging and dosing standards.
Finally, let me give a bit of color to the importance of some of the trial logistics that can affect inclusion. Consider location of the clinical trial site and the travel requirements for patients. The clinical trial protocol outlines the requirements for laboratory tests, imaging, and follow-up visits. These visits can equate to loss of income and increased childcare and travel costs. They may also prohibit patients who have ambulatory issues. Could those visits be completed virtually or at a satellite location that is more convenient?
Barriers for the Potential Volunteers
There are also significant factors that impact potential participants’ willingness to enroll in a clinical trial, and they will require combined efforts to solve.
The first and potentially most challenging barrier for the larger community is awareness. Not many people know what a clinical trial is, or they may have misconceptions about them. Moreover, assuming a patient is seeking a trial for a disease, how would they find one that is right for them? How does that person go about enrolling? What can we do as a research community to increase awareness and answer their questions?
Another major hurdle is a sense of concern or mistrust about clinical trials. Historically, there have been atrocities committed in the name of clinical trials, and those have become a part of the community’s awareness of what a trial is. We, as a research community, must be clear and direct on the provisions that have been put in place to protect patients. We should also consider including trusted members from the community on advisory boards to help better inform and establish a connection between participants and the protocol.
There is also a pervasive sense that the healthcare research community reaches out to underrepresented communities when they need participants for clinical trials, but are not responsive or committed to the community when the community is in need. We have heard from some that researchers are only involved in the patient communities when they need to fill clinical trials. To that effect, there is a whole host of work that can be done to become a true partner with the community.
The Road Ahead
I stated at the beginning that any honest assessment of clinical trials must start with the truth that we are not where we want to be in terms of diversity and clinical trials. But I think that there is a road ahead – and it is partially paved for a way forward. It will require help from the entire research community to finish the pavement and make it a high-speed highway. We must put in the work to establish the partnerships and create the collaborations to ensure the inclusion of all communities and ultimately deliver better health outcomes to everyone.
Freda Lewis-Hall, MD, DFAPA, MFPM, is a pioneer in medicine, having spent more than 40 years on the frontlines of healthcare as a clinician, researcher, and leader in the biopharmaceutical and life sciences industries. She was formerly Executive Vice President, Chief Medical Officer, and later Chief Patient Officer at Pfizer, Inc. She is a member of the Foundation’s Board of Directors.
This blog has been adapted from Dr. Lewis-Hall’s recorded presentation for the 8th International Symposium on Focused Ultrasound, held in October 2022.