Minimizing distrust, explaining process essential to increasing trial participation
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ORLANDO, Fla. — Explaining the details of the clinical trial process is critical to minimizing barriers to research participation, according to a presenter at the 2024 Rheumatology Nurses Society annual conference.
“The purpose of clinical research is to improve the lives of our patients,” Barbara Kienzle, BSN, RN, a pediatric rheumatology nurse clinician at Augusta University’s Children’s Hospital of Georgia, and a member of the RNS board of directors, told attendees. “It is always to help other people.”
Unfortunately, many patients do not view clinical trial participation in that way. According to Kienzle, lack of interest, time commitments, competing life demands, transportation costs, fear of adverse events, health literacy and distrust are all barriers to participation.
“Looking at that list, I want to hone in on the bottom two,” she said.
Health literacy ties into broader issues pertaining to socioeconomic status and educational opportunities, according to Kienzle.
“If your patients do not understand their disease process, they are not going to understand the need for the research,” she said.
Meanwhile, examples of poor research and abuse — in both the distant and not too distant past — have fostered feelings of distrust among some patients.
“There has been a lot of bad research out there,” Kienzle said. “There has been a lot of abuse of research participants.”
To address this situation, Kienzle suggested tailoring conversations about trials to each individual patient, and providing multilingual, easily understandable materials on the trial itself.
“We make sure they know everything they can about the disease process and the treatments for it,” she said. “We try to teach them what clinical trials are and assure them that they are safe.”
Importantly, providers should be intimately familiar with all of the rules and regulations that surround a clinical trial.
“If you are involved in clinical trials and have ever had to do CITI [Collaborative Institutional Training Initiative] training in clinical practice, you know that that is a very daunting task,” Kienzle said.
She added that perhaps the most important point for patients to understand is that clinical trial participation is voluntary.
“When you are talking to your patients about clinical trials, two things should be very clear,” Kienzle said. “One is that it is voluntary. Their care that you are giving them is not going to change regardless of their decision. If they say no to a clinical trial, that is absolutely OK.”
The second point is that the patient has the right to stop at any time.
“With any good research coordinator, the first question they will ask is: ‘Do you want to continue with this study?’” Kienzle said.
Even children, adolescents or other vulnerable populations have the right to decline or stop at any time, according to Kienzle.
“We have teenage patients who are in the ‘putting their foot down’ stage of life,” she said. “If they say no, we have to take them out.”
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Kienzle B. Clinical Trials, New Therapies, and Additional Indications. Presented at: Rheumatology Nurses Society annual conference; July 17-20, 2024, in Orlando, Florida (hybrid meeting).
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