Survey: Flexibility in Clinical Trial Approaches is Paramount to Participation
Patients have spoken: Flexibility, including the option of in-person visits, is still vital to their willingness to take part in trials even after the pandemic made remote and virtual approaches the norm, a global survey has found.
Specifically, 44 percent were semi-willing and 38 percent were very willing to do all study visits at the clinic itself and see staff exclusively in-person, according to Shalome Sine, project manager of research services for the Center for Information and Study on Clinical Research Participation (CISCRP), who presented the survey findings last week at MAGI’s Clinical Research Conference.
Forty-four percent were somewhat willing and 37 percent were very willing to take part in a hybrid trial model in which some study visits are done at home, some are in the clinic and some interactions take place remotely. For trials in which a nurse comes to the home for all visits and study staff communicates only by video call, 41 percent of patients were somewhat willing and 36 percent were very willing to participate. And for trials in which all health data are self-collected at home and the only study team communication is by video conference, 40 percent were somewhat willing and 34 percent were very willing to take part, the lowest levels of willingness on the list, the survey found.
“The way I interpret this is … highlighting the importance of options. Every clinical trial participant is different and has different things going on in their busy lives. Giving them flexibility of options, or at least different clinical trial models, can really help to impact the way that people stay in clinical trials and their ability to remain enrolled for the full duration of the study,” said Sine.
While patients appreciate and are interested in virtual and remote components that can make participation more convenient, some are worried that these approaches of the future will supplant the classic in-person model, according to Ken Getz, founder of CISCRP. Face-to-face interaction in trials is in fact still very important to some patients despite the leaps and bounds industry has made in using technology to remotely conduct studies, the survey found.
“We get very, very excited about virtual and remote support, and patients are telling us that these are important options for them, but they also have concerns about [if they will] replace some of the more personal interactions that they might have with study staff,” Getz said during the Greenphire Patient Convenience Summit last week. “Patients are really looking for a balance between impersonal and personal, or high-tech and high-touch.”
CISCRP’s biannual global survey questioned 5,505 trial participants and 6,288 people who had never participated to gauge what it takes for them to enroll and stay in a trial. The survey’s findings offer important insights on the effect the pandemic has had on patients’ expectations and perceptions of clinical research.
Notably, respondents who had participated in trials named a number of trial elements as difficult far more often than those surveyed in 2019. Traveling to the study site was named as somewhat or very burdensome by nearly half (44 percent) of respondents compared to just 29 percent two years prior. Similarly, 42 percent of respondents said that having to go through diagnostic tests like x-rays and MRIs was demanding, double the percentage seen in the 2019 survey. And 40 percent of this year’s respondents found the length of study visits draining, nearly twice the amount in the last survey.
Other activities were named burdensome by double or more the percentage seen in 2019: Lab work (38 percent compared to 17 percent), taking the study drug (37 percent to 15 percent) and completing health questionnaires (32 percent to 18 percent) were all named as somewhat or very burdensome by participants to a much greater degree.
Respondents also shared approaches that they felt would have made their trial experiences less disruptive. Virtual study visits were named by 38 percent of respondents, as well as shorter travel distances to the study visit (32 percent) and home visits (31 percent). Respondents also felt that prepaid debit cards for study-related expenses (27 percent) and travel assistance (24 percent) would have been helpful.
Those who never participated in a trial were asked how important it was for them to know certain information prior to enrolling. Potential risks and benefits (77 percent) took the top spot, followed by the purpose of the clinical trial (71 percent); information about the drug being studied (68 percent); the types of medical procedures required (67 percent); and how patient confidentiality would be protected (62 percent).
A little more than half of respondents said they would want to learn about data from earlier phase studies on the drug, if they would receive a summary of study results after participation, the potential costs and reimbursements, and the length of participation before enrolling. Half said the actual location of the site was important for them to know before they’d decide to sign up or not.
Patients also ranked factors they felt were most likely to keep them in the trial until its completion. The No. 1 retention factor for respondents was seeing/feeling benefit from the drug. This was followed by (2) regular updates on research progress, (3) study visits with flexible times, (4) reimbursement for out-of-pocket costs and (5) the option of doing at-home study visits instead of in the clinic.
They also named (6) a larger amount of compensation at the trial’s end, (7) small amounts of compensation per study visit, (8) study visits lasting no longer than an hour, (9) transportation to and from the clinic and (10) childcare as things most likely to keep them enrolled through the length of the trial.
The top motivators for participating in a trial were in line with the findings from CISCRP’s 2019 survey, with 39 percent of those who had participated in a trial citing the advancement of science and the treatment of their disease/condition as a reason they enrolled. Thirty-one percent said they sought to help others who may have their disease/condition while 30 percent enrolled for the monetary compensation. Obtaining education about treatment and improving their health and obtaining better treatment for a disease/condition was named by 25 percent of respondents, while 24 percent said they were influenced by the information they received about the study.
There was a small decrease in willingness to participate in a clinical trial from 2019. Polling all respondents, the survey found that only 30 percent indicated they were very willing to enroll in a trial compared to 34 percent two years prior. On the other hand, 47 percent said they were somewhat willing to participate, slightly higher than 2019’s 45 percent.
Of respondents who participated in trials and those who had never joined one, 19 percent said the pandemic had made them more hesitant to sign up. Forty-three percent of those who never participated said they were more likely to enroll due to the pandemic, while 29 percent of trial participants said they were more willing. More than half (52 percent) of trial participants said it had no impact on their willingness compared to 38 percent of respondents who had never joined a trial.
The study has not yet been released in full and will be published in early November, a CISCRP spokesperson told CenterWatch Weekly. The center will hold a webinar on Oct. 27 to review the survey data in-depth.