Doctors misjudge SCD clinical trial motivations, US study finds
Suggestions target more effective communication to boost patient participation
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In the U.S., doctors who care for people with sickle cell disease (SCD) often don’t have a clear understanding of what motivates patients to participate in clinical trials, according to a survey-based study called LISTEN.
Based on the findings, researchers offered a range of suggestions for how doctors can more effectively communicate with their SCD patients to encourage trial participation.
They called for doctors to be proactive about discussing potential side effects and sharing how trial participation can further scientific knowledge and support the SCD community. Researchers also called for community efforts where people with SCD who have participated in trials can share their experiences with other patients.
“The questions posed to PwSCD [people with SCD] in the LISTEN Survey … could be repurposed by HCPs [healthcare providers] in the office setting to identify the individualized concerns of their patients and to have truly tailored conversations,” researchers wrote.
The study, “Motivators and Barriers Affecting Decisions to Participate in Clinical Trials for Sickle Cell Disease: United States Findings from the Quantitative LISTEN Survey,” was published in the Journal of Racial and Ethnic Health Disparities. It was funded by Novo Nordisk, which is planning to seek approval of its experimental therapy etavopivat for SCD in the coming months.
Doctors underestimate impact of side effects on participation
Clinical trials — rigorously designed scientific studies in people — are the gold standard for testing whether new treatments work or not. However, in order for trials to be run successfully, it’s vital that patients with the relevant condition are willing and able to participate.
A Novo Nordisk-led team of researchers conducted an international survey, called Learnings and Insights into Sickle Cell Trial Experiences (LISTEN), to better understand the most important motivators and barriers to clinical trial participation for people with SCD.
The survey was completed by SCD patients themselves and also by doctors who care for people with the disease. Data from survey participants outside the U.S. have already been published.
Interestingly, responses varied between PwSCD and HCPs for several factors, which underscores the importance of identifying the key motivators and barriers from participants’ perspectives to improve recruitment for trial participation.
In this study, the researchers described results from LISTEN survey respondents living in the U.S., including 193 SCD patients and 76 healthcare providers. The team noted that location of participants strongly reflected the location of people living with SCD in the U.S.
“Interestingly, responses varied between PwSCD and HCPs for several factors, which underscores the importance of identifying the key motivators and barriers from participants’ perspectives to improve recruitment for trial participation,” the researchers wrote.
For example, doctors overestimated the extent to which travel or more frequent blood draws or other tests would discourage participation. Providers underestimated how much getting to regularly see a specialist might be a motivating factor for patients and how different side effects of the trial treatment could discourage participation.
But the largest discrepancies, specifically underestimations by doctors in terms of motivators, were seen in wider clinical trial outcomes, including supporting the identification of treatments that will benefit patients themselves and others, as well increasing the patient’s knowledge about the disease.
“These results also suggest HCPs could more effectively address PwSCD clinical trial concerns by (1) discussing potential side effects in more detail, (2) highlighting the opportunity to see an SCD specialist more often, (3) emphasizing how participation could improve their knowledge of SCD, and (4) explaining how participation may support future treatments for themselves and other PwSCD,” the team wrote.
Patients more likely to trust information from others with SCD
Another notable discrepancy concerned sources of information used to learn about trials. Doctors said they usually refer their patients to the pharmaceutical company sponsoring the trial or to information available through medical centers or the internet. But SCD patients said they were more likely to trust information given by other people living with SCD or their own doctors.
This “suggests a need for 1) additional materials or speaking opportunities designed to be distributed via the channels most preferred by patients and are patient-focused to alleviate any concerns or questions patients might have about trial participation, 2) programs to coach HCPs on effective communication with patients concerning clinical trial information, and 3) services led by patient advocacy groups that identify volunteers and provide a means for them to discuss and share their clinical trial experience with other patients in the community,” the team wrote.
Among SCD patients, thoughts about clinical trials varied to some extent based on demographic factors including sex, education, and socioeconomic status.
For example, college-educated patients and patients with higher incomes were generally less concerned about travel requirements than those who with less formal education or lower incomes. Based on these findings, the researchers offered tips for how doctors might tailor discussions about trial participation for patients with different backgrounds.
“Together, these findings can be used to guide discussion and improve communication between HCPs and PwSCD considering, or actively participating in, a clinical trial,” the researchers wrote. “Finally, insights … [also] can be used by trial sponsors to improve the design and delivery of future clinical trials to enhance patient recruitment and ensure that the needs of the SCD community are kept at the forefront.”
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