NC TraCS program alumni are researching the patient side of clinical trials

UNC physician Marc Bjurlin teamed up with his colleagues from the Clinical Trialist Training Program on a unique series of studies aimed at improving and expanding clinical trials.

Clinical trials, the scientific process of testing the safety and effectiveness of new medications and medical techniques, require a lot of work to get off the ground. Researchers need lab space and equipment, board reviews, data management plans, expertise in statistical analysis, research assistants, and clinicians to work on the trial—and, of course, funding to pay for the whole thing.

But most of all, to run a clinical trial, researchers need patients to actually sign up to participate in that clinical trial.

Marc Bjurlin, a urologic oncologist at the University of North Carolina, is now trying to solve the puzzle of how to get more people into the scientific research process, and offer more patients cutting-edge medicine.

A few years ago, Bjurlin signed up for the Clinical Trialist Training Program (CTTP) offered by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute, which guides researchers through the nitty-gritty logistics of overseeing a clinical trial. With support from his colleagues in the program, Bjurlin has now also published a series of papers looking at patient perspectives and experiences in clinical trials.

"The Clinical Trialist Training Program gave us a lot of resources and foundation and structure to run and develop a clinical trial."

"The Clinical Trialist Training Program gave us a lot of resources and foundation and structure to run and develop a clinical trial," Bjurlin says. "And I think this set of studies we did kind of added a new flavor into how our patients may actually think from their side of the clinical trial, rather than from our side as the physician running the trial."

When Bjurlin joined UNC, part of his responsibility as the urology department's director of clinical trials was to bring more trials to the hospital. At the time, he had some experience with clinical trials, including a master's in clinical investigation from his fellowship at New York University, but not the level of formal training offered by the CTTP at NC TraCS.

The CTTP is a one-year program that provides researchers and clinicians the skills and expertise they need to run and design clinical trials, such as budgeting, patient recruitment, and working with institutional review boards. This includes regular meetings and a four-part clinical trial "bootcamp" that covers many of these topics. For faculty members at the UNC School of Medicine, the CTTP can even cover 10% of their salary for the year.

Bjurlin says the program gave him "way more depth, knowledge, nuts and bolts of how to vet a study, how to assess it, how to get it up and running, how to accrue, how to enroll."

Around this time, Bjurlin was also doing some research with the Health Information National Trends Survey (HINTS), which gathers data on how Americans understand, learn, and think about healthcare, with a focus on cancer. He was interested in learning more about why people may or may not participate in clinical trials. And as he got into this work, he thought that his fellow participants in the CTPP—Donna Culton, a dermatologist at UNC, Kristalyn Gallagher, a breast surgical oncologist at UNC, and Kimberly Weaver, a gastroenterologist formerly at UNC—would be a great resource and sounding board for this research.

"Let me do the analysis and then I'll circle back with the group to see what they have to think in terms of, does this data make sense? Is this an interesting finding? Is it something we could write up into a paper?" Bjurlin says.

Bjurlin, his CTTP cohort, and some other colleagues have now published three papers looking into patient experiences on clinical trials. The most recent, published in June in Tumori Journal, dove into the HINTS data to study patient participation in trials among people who have had cancer.

The paper notes that many trials never recruit enough patients—and according to HINTS, just 7.4% of people with cancer participate in a clinical trial. But prior research has found that, if given the opportunity, around 32% of Americans would be interested in being part of a clinical trial for cancer.

Awareness and patient education may help solve part of this puzzle. More than half of the survey respondents said they had a little knowledge of clinical trials, around a third said they had no knowledge, and less than 10% reported a lot of knowledge. Just 13.5% of respondents said that a clinician discussed a clinical trial for cancer with them, and only 15.7% of people reported being invited to participate in a clinical trial—but nearly 38% of people who were invited to a trial reported participating in that trial.

Logistics may play a role in clinical trial participation, too. About 42% of people said that transportation, childcare, or getting paid time off work would be at least somewhat important to their ability to be in a trial.

Some patients also seemed to be more aware of, or more likely to be invited to, trials than others. For example, patients with less education were more likely to have discussed clinical trials with a clinician. At the same time, being invited to a clinical trial was associated with higher education, as well as living in a metro area (as opposed to more rural areas.)

The paper covered a range of other nuances around potential roadblocks to participation—and Bjurlin has seen patients navigate some of these challenges himself. He notes that many of the cancer patients at the UNC hospital in Chapel Hill aren't local and come to the Triangle from other parts of the state to receive care, which can be challenging.

"I need to find someone to take care of my daughter, I need to make sure my significant other is taken care of, I need to pay for the gasoline to get here and back, I need a hotel to spend the night," Bjurlin says.

In addition, he points out that clinical trials are often run out of large practices or academic centers like the hospital in Chapel Hill, but many patients get care from other kinds of healthcare settings. As a result, their doctors may not even be aware if there is a clinical trial available for them.

And yet, the team's recent paper also revealed that people have all kinds of reasons for wanting to participate in a trial. Almost three-quarters of respondents said getting a chance to try a new treatment would have an influence, with almost 89% listing "wanting to get better" as a potential motivating factor. Around 40% said being paid would be a motivating factor—and more than 70% of people said that getting a chance to help others would influence their choice to participate.

To help get more people connected to trials, Bjurlin notes the importance of simply raising awareness of clinical trials. He also points out that UNC has the Research for Me website where patients can check to see if there are any clinical trials available they might qualify for.

Overcoming these challenges could help more patients participate in clinical trials and get next-generation medical treatments. And on top of that, getting more people into clinical trials today can expand the boundaries of medical knowledge and opportunities—helping future patients get safe and effective treatment tomorrow.