Fall 2021

The truth about clinical trials

Separating the facts about participating in research studies from fiction

Participating in research can be as easy as donating an extra vial of blood in the lab or consenting to sharing deidentified data from a medical record.

Over decades, tens of thousands of clinical research studies, also called clinical trials, have helped physician-scientists bring new treatments and even cures forward to help patients.

“Anyone who has participated in a clinical research study has given an amazing gift,” says Bradley Benson, M.D., chief academic officer for M Health Fairview and a professor in the University of Minnesota Medical School. “Every one of those studies gets us closer to treatments that change lives.”

Here, Benson offers up the facts about clinical research, dispelling some common misconceptions and explaining why participation matters.

There are no “guinea pigs.”

“That phrase makes me shudder,” Benson says. “Long before we bring any people into a study, incredibly rigorous work has already been completed that ensures safeguards are in place.”

At the U, the Human Research Protection Program independently develops protective measures for all research participants and monitors safety procedures throughout the studies. It also ensures that study participants can change their minds and withdraw from a trial at any time.

“I think many people also don’t fully appreciate how deeply our researchers care about the participants in their trials,” Benson adds. “They are completely invested in trying to discover better, more effective treatments for patients.”

Some studies focus on preventing disease.

One current trial, for example, looks at the impact of ginger extract on the gut microbiomes of people who have had colon polyps removed. 

Based on research done at the Hormel Institute and the Masonic Cancer Center, University of Minnesota, the study aims to determine whether ginger’s anti-inflammatory properties can help reduce the risk of colorectal cancer.

Finding out what doesn’t work can be as important as finding out what does.

When the COVID-19 pandemic swept across the globe last year, doctors were faced with a serious new disease they knew little about. They needed information fast. 

Within a month of admitting their first COVID patient, U doctors had launched a bedside study on the efficacy of the drug losartan, followed quickly by more studies evaluating such treatments as hydroxychloroquine and metformin. Typically, it takes about a year to get studies like these up and running.

“We published some of the first papers showing that hydroxychloroquine and losartan didn’t work,” Benson says. “Once we learned which treatments didn’t show benefits, we refocused quickly on ones that did.”

Simply sharing your deidentified patient data can help drive breakthroughs.

Patients getting care at a large academic health system like M Health Fairview are often asked to share their patient data, anonymously, to help researchers. 

According to Benson, that kind of data proved invaluable during the worst of the COVID-19 pandemic. Researchers aggregated all the data on COVID patients they’d seen, then used machine-learning technology to develop an algorithm to predict which patients had a 90% chance or greater of returning to the hospital with more severe illness. Doctors used that predictor to send some patients home with monitors or oxygen supplies; they stayed in touch with other patients with daily texts.

“It made a difference,” Benson says. “We caught more serious illness quicker.”

Research happens outside hospital and clinic walls, too.

One recent U of M study aimed to improve survival rates for people who suffered cardiac arrest by changing the treatment protocol and bringing emergency-room care to patients wherever they were. “This work in the field has been dramatically helpful in pointing us toward new ways to care for people experiencing cardiac arrest outside the hospital,” Benson says.

In fact, this community-wide program, the first of its kind in the country, proved to be so much better than the former standard of care—with 43% surviving vs. 6.7%—that the study was stopped early so everyone could access the new protocol.

Clinical research leads to better treatments.

University researchers are at the forefront of an international effort to develop cellular therapies that exploit the body’s own immune system in an effort to control or cure cancer.

Today M Health Fairview physicians are overseeing dozens of clinical trials that are evaluating the effectiveness of new immunotherapies for a wide range of cancers that affect adults and children.

“When I look into the future,” Benson says, “my hope is that we will view chemotherapy as a treatment of the dark ages. New cellular therapies offer incredible promise for serious cancers and rare diseases, and every time a patient enrolls in one of these studies, it moves us closer to the cure.”

Philanthropy can help to bring leading-edge therapies to patients. Contact Shawn Keenan at 612-625-7223 or skeenan@umn.edu to find out how your gift can make a difference.

Anyone can contribute to medical knowledge.

“My children, my spouse, and I have all been involved in clinical research,” Benson says. “We are all partners in this discovery process, and each bit of information helps us move forward.”

Get involved >> The University of Minnesota is actively welcoming participants into clinical studies of cancer, women’s health, cardiology, disease prevention, and more. To find out how you can get involved, visit studyfinder.umn.edu.