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ROCHESTER — This spring, over the course of several weeks, Alexandra Mackenzie-Roberts took two pills a day. She doesn’t know if it was an actual medication or a placebo.
Mackenzie-Roberts, a Rochester resident who lives with long COVID and myalgic encephalomyelitis/chronic fatigue syndrome, is among millions of Americans who have participated in a clinical trial: research that tests some sort of intervention — be it a medication, exercise plan, medical device, food and more — on human subjects.
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The question posed in Mackenzie-Roberts’ trial: Does a particular medication reduce brain fog and fatigue in those with long COVID?
“I have ME/CFS; it’s not a very well-studied … or well-treated condition,” Mackenzie-Roberts said. “I was hoping to contribute to that science of finding something that would work for people like me.”
About 5% of Americans report participating in a clinical trial, per data from the 2020 Health Information National Trends Survey. Many more report that they don’t know anything about clinical trials. It’s one of the biggest barriers to participating, said Aisha Langford, an associate professor in the Department of Family Medicine and Public Health Sciences at Wayne State University School of Medicine in Detroit.
“A lot of times, people aren’t invited, explicitly, to participate,” Langford said.
Opportunities to participate in clinical trials are relatively abundant in Southeast Minnesota, through Mayo Clinic and other research institutions. And one doesn’t necessarily need a particular diagnosis to participate — many trials recruit healthy volunteers, people who don’t have the condition being studied. Mayo Clinic alone has more than 400 open clinical trials for healthy participants in Rochester, according to its online directory.
For this story, the Post Bulletin reached out to Mayo Clinic, which did not provide additional information on its clinical trials nor an opportunity to speak with an expert.
For researchers, clinical trials are a key step toward verifying a new cancer treatment, a new use for an existing drug, or evidence that exposure to a certain substance is harmful. Clinical trials are part of the continual exploration of science and health — without them, progress would stop, said Heather Pierce, senior director for science policy at the Association of American Medical Colleges.
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“The continual improvement in options and in health are driven by a legacy of those who came before you,” Pierce said. “Being part of that is actually, I think, very exciting.”
In Austin, the University of Minnesota’s Hormel Institute focuses on cancer research. While much of that work relies on animal models, such as mice, or in vitro tissues in Petri dishes, some studies involve human subjects.
One trial, led by professor of food science and nutrition Leena Hilakivi-Clarke, is studying how soy milk, cow’s milk and dietary fiber can impact women’s breast cancer risk. Through blood draws and stool samples, researchers will measure the impact of those foods on the gut microbiome and the body’s inflammatory response.
Hilakivi-Clarke said she anticipates mixed results — soy milk’s properties might be protective for some women, for example, but not all.
“The idea is that every person responds a little differently to the same food,” Hilakivi-Clarke said, “and that’s the reason why we can’t say, ‘Everybody drink milk, that reduces your breast cancer (risk).'”
Another trial is exploring what diet and lifestyle interventions will work best for breast cancer survivors. Led by Annie Lin, an associate professor of nutrition informatics, researchers are building the ForkCancer Pals program with input from breast cancer survivors themselves.
“We’re trying to dig deep into what exactly they want,” Lin said. “We’ve been refining it over time with the focus groups.”
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Back in Rochester, the Well Living Lab's research focuses on how light, air quality and other environmental factors within indoor spaces affect human health. As such, the lab’s human subject studies often take place in real environments, such as schools or nursing homes, or in its coworking space and apartments in downtown Rochester.
“We’re trying to be proactive in our environmental changes to help folks inside the space to be healthier,” said Chi Lam, the lab’s director of technology.
Well Living Lab trials often involve healthy participants, but research findings can potentially apply to people with certain conditions, too, said research scientist Eric Snyder. He cited a recent trial on stove hood ventilation. In one group, the hood fan automatically turned on when the air quality declined during cooking. In the other group, participants had to manually turn on the fan.
“We found that with the automated ventilation, there was much better lung function and there was less exacerbation of blood pressure,” Snyder said. “So you can imagine then translating that to hypertensive patients and asthma and COPD patients.”
Before an idea, a drug or a device is tested on human subjects, it has most likely been studied on mice or other animals, on tissues in test tubes or in other lab-based studies.
“If it shows promise in the lab, in animal models, it’s only then that it may proceed into human subjects research,” Langford said.
In the U.S., institutional review boards oversee research done on living people. These boards, Pierce said, review proposed trials to ensure participants’ safety.
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“When you get to the point where someone has the opportunity to participate,” Pierce said, “the trial has already gone through extensive review about the science, about the ethics, about the risks and the potential benefits, either to the person or to society at large.”
For the Well Living Lab, the location of a given study will depend on what researchers want to measure, how they can measure it, who is participating and how many participants are needed. It would be more difficult to set up air ventilation monitoring in people’s homes versus using that equipment in the coworking space, said Linhao Li, research and development technical manager.
“But if we’re doing a lighting study, we can just provide the light bulb,” Li said. “They can install it themselves, and that’s much easier for us to do in homes.”
Another aspect of the trial planning process is participant burden, the amount of work and time a person will have to give as part of a study.
“If we’re expecting the participant to spend eight hours a day solely focusing on this study and they can’t do anything else, that’s going to be a pretty hard study to recruit for,” said Eric Heins, Well Living Lab’s director of operations.
Many clinical trials will give participants a small payment, called remuneration, as compensation for their time spent in the study.
“That has to match the level of burden, but we can’t overcompensate, as well,” Heins said.
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Langford, the Wayne State associate professor, said clinical trial participants often hear about those trials through their healthcare provider, “especially, but not exclusively, if they are treated in an academic medical center.”
That was the case for Mackenzie-Roberts, the Rochester long COVID patient, whose Mayo Clinic doctor told her about the clinical trial she took part in.
“It’s just really important to me to contribute where I can,” Mackenzie-Roberts said.
Other participants, Langford said, learn about trials through the federal government’s ClinicalTrials.gov or disease-specific advocacy groups.
And some trials, such as the Hormel Institute’s milk and fiber study, use direct-to-consumer advertising on social media.
“That might be a little bit less common, but I think, especially during COVID,” Langford said, “I was seeing more things about COVID-related trials and other types of research opportunities … through Facebook.”
Both the Well Living Lab and the Hormel Institute see repeat participants or those who learn about studies through word of mouth.
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“We get a lot of healthcare workers that are just really passionate about the health of their community,” said Megan Moe, clinical research and outreach coordinator.
A common pain point for many clinical trials is not being able to recruit enough participants. Langford said under-enrollment can delay or even halt studies.
“If you don’t get enough people, your clinical trial may be underpowered, which means you may not have enough people to show, statistically, that something has a real effect,” Langford said.
Sometimes, low recruitment means the trial’s whole design must change. Heins said the Well Living Lab ran into this when it tried recruiting people for a carbon dioxide and cognition study. During the height of the COVID-19 pandemic, not many people wanted to spend three full work weeks, around other people, in the lab’s coworking space.
“We went back to our partner and redesigned the study where it was work from (the lab) full-time for a week, work from home for a week and then work wherever you want for a week,” Heins said. “We were able to get 75 participants in.”
For researchers, that willingness to participate is crucial — trials cannot happen without volunteers. Lin, the Hormel Institute cancer survivorship researcher, said she is inspired by her trial’s participants.
“They want to help those who are going through this journey,” Lin said. “This is just so much for the social collective good.”
The clinical trial process can take years. Human subject studies at the Well Living Lab, Heins said, take 12 to 18 months, from start to finish.
Participants might not know the trial’s outcomes until well after they tried a medication or followed researchers’ exercise plan. Sometimes, participants want to not only see the results of the research, but their own information. It can be difficult to do that, Pierce said.
“There are data aggregation issues where you can’t always say … ‘You were on this exact arm, and this is what happened with you specifically,'” Pierce said.
And the information itself might not even be relevant to that person — data collected during a blood draw years ago might not have any bearing on one’s health today. It can take even longer, Pierce said, until “the collection of many pieces of research together turns into an actionable step.”
“There are a lot of conversations right now, across the federal and academic communities, about how we honor the participation of individuals by making sure they know what happens,” Pierce continued.
Mackenzie-Roberts said she is interested in reading her clinical trial’s results, once available.
“I want to know how it turns out,” Mackenzie-Roberts said. “It’s kind of cool to think that I’m contributing to science.”

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