For the past several months, I have participated vicariously in the early stages of a clinical trial. The trial is testing a drug that might significantly reduce the severity of my son’s food allergies. The scientist in me has found the experience fascinating. The mother in me found the part where they give him the food we’ve avoided for 15 years to intentionally provoke a reaction rather stressful. The social scientist in me has now seen firsthand some of the factors behind a troubling reality: most trials are not representative.
According to a recent article in the Harvard Business Review, “Clinical trials primarily enroll white, male patients, with consistent underrepresentation of women, the elderly, and people of color — especially Black and Hispanic patients. While people of color make up about 39% of the U.S. population, these groups represent from 2% to 16% of patients in trials.” Companies rarely face public scrutiny over the composition of their trials and the FDA doesn’t mandate trials be representative of the disease or the population.
The implications are significant. A lack of representation from racial and ethnic minority groups in clinical trials has resulted in the development of drugs that have not translated well into real-world use, have not been effective in different populations or worse, had toxic side effects that turned out to be much more prevalent in people of color.
The pandemic has shined a spotlight on the disparities in health care, and research is no exception. Research physicians advocating for more representative populations have recommended setting intentional recruitment goals, tapping patient registries, and moving beyond the academic medical center into health systems. From my own “participant” lens, I have some other ideas.
Bring studies to the participants, through employers
The most challenging part of this clinical trial is just the time involved. Ours may be extreme, but my son will have no less than 7 visits just to get into the trial. Then bi-weekly appointments for two years. If you don’t have a flexible schedule, which many front line and hourly workers do not, it would be very challenging to participate. Yet the vast majority of what happens at these appointments could be brought to a clinical setting in a workplace or school. Partnerships between researchers and workplaces could dramatically improve access to diverse populations and make participating much more feasible.
Develop a consistent reimbursement scheme
Clinical trial compensation schemes are all over the board. Ours only funds the cost of parking at the hospital. Some pay a minor stipend in the $50-$75 range. If you ever ride the subway in Boston, you will see numerous ads trying to recruit participants offering thousands of dollars. This controversial practice raises ethical questions about “undue inducement”. Having some sort of standard reimbursement scheme, looking most notably at time required and then adjusting for risk (ie Phase I vs. Phase III), seems like it could ensure representation while reducing risk of disproportionately coercing lower-income participants.
Use other participants to recruit
The clinical team recruiting for our study is not diverse itself. There is research that shows health outcomes improve when the physician is the same race as the patient. My hypothesis is that medical research recruitment outcomes are likely similar. So if the clinical team isn’t diverse, what can you do to connect more with diverse participants? We know people are influenced by seeing “people like them” doing things. So actively using other diverse participants as patient advocates to share their experiences could drive more participation.
Last but certainly not least, the medical community must acknowledge the mistrust that exists in minority communities due to prior research abuses. The best way to build trust is to build relationships. That means that as busy as they are, research physicians will be well served to prioritize getting out of the hospital and into the community.
Quote of the Week: “I think the biggest problem in clinical trials is that they are underpowered. And that fundamentally, the studies are just too small.”Anne Wojcicki