Hybrid Trials Are Impacting Clinical Research, But Do Patients Want Them?
By Ed Miseta, Chief Editor, Clinical Leader
Clinical trials continue to evolve and have become increasingly complex. Studies now have more procedures, visits, and time spent at clinics during those visits. Studies also have narrower inclusion criteria and longer travel times to clinics. Those factors have been building for years and have created additional burdens for patients.
The Center for Information and Study on Clinical Research Participation (CISCRP) is celebrating its eighth year of focusing on the patient experience in clinical trials via its Perceptions and Insights study. Founder Ken Getz notes the mission of the non-profit group is to educate and engage patients, the public, and other stakeholders.
The survey is conducted worldwide and CISCRP works with many organizations, pharma companies, patient advocacy groups, foundations, government agencies, and research centers to reach a large number of patients. Approximately half of respondents are from North America and another 30% to 40% from Europe.
The world has had to deal with COVID-19 since the last time the survey was conducted, and the pandemic made it more difficult for patients to participate in trials. Although media coverage of vaccine development in 2020 helped educate the public on the need for clinical research, what surprised Getz the most is that the pandemic did not have a measurable impact on the attitudes and perceptions that patients have about clinical trials.
“We saw high ratings in terms of the quality of patient's experiences in clinical research along with a high willingness to repeat participation,” says Getz. However, despite the industry shift towards patient centric practices, Getz notes, “the fundamental measures around the burdens of participation and their influence on the decision to participate only changed slightly.”
One example of the changes that took place was the move to decentralized and hybrid trials. Those changes also raised concerns for patients, such as whether remote visits would replace the personal interactions patients had with study staff. Getz believes patients are looking for a balance between personal interactions and the use of new technologies. He notes patient preferences vary based on the therapeutic area, geography, and other factors.
What Do Patients Need To Know?
One of the questions patients were asked is what they want to know when deciding whether to participate in clinical research. Most patients express the greatest interest in understanding the purpose of the research. That is followed by the desire to understand inherent risks in the trial, benefits of the study medication, and costs/reimbursement. Once patients begin participation in the trial, logistics become an even more important consideration.
“Reimbursement plays a key role in trial participation,” says Getz, “especially in virtual (decentralized) trials. It's an important factor that makes patients feel connected and valued. In North America close to 60% of trials offer cost reimbursement to patients. The form of reimbursement varies, with the most frequent being cash, check, and debit card.”
Travel was another issue that generated a good amount of feedback. When compared to prior surveys, there was no major change in the willingness of respondents to travel. However, clinical trial participants still view travel as being disruptive to their daily routines. Survey respondents expressed high interest in minimizing travel and having more flexibility regarding when to participate.
For patients who were forced to travel, that journey generally took between 30 and 60 minutes. For 25% of patients, the travel time was more than an hour. Although travel is disruptive to work and family time, when asked if they would like their site visits replaced with virtual trial components, patients indicated they were willing to travel. Even patients with the most severe medical conditions were willing to travel to appointments.
“That seems almost counter intuitive,” notes Getz. “It tells us patients value personal relationships. They want to have some in-person engagement with a specialist or study team. That preference for personal engagement also coincides with unmet medical need and participants wanting to manage the burden of their disease. When patients are dealing with a diagnosed medical condition, particularly one for which there is not an adequate therapy, there's a much greater need to do whatever it takes to advocate for oneself and to integrate a trial into their daily life.”
Trust Brings Long-Term Participation
Drug companies want to recruit patients who will engage with a trial for the duration of the study. So, what factors will keep patients engaged for the long term? The studies conducted by CISCRP have found the most critical factors to be quality of the relationship with study staff and the amount of trust that exists between staff and the study participants.
“A lot of it has to do with whether their expectations were met,” states Getz. “Did their expectations coincide with and affirm what they were expecting when they completed the informed consent process? Their relationship with and trust in the study staff played a role. The feedback they received throughout the study and communication with site staff is very important. A high percentage of respondents noted they had a positive experience participating in their trial even when the investigational therapy offered no benefit to them.”
Over the last two years respondent perceptions of their quality of care in the clinical study was up materially. Still, for some subgroups, fewer patients participating in a trial noted they would do it again. That finding may again show that while patients value the convenience of decentralized trials, remote engagement may result in fewer interactions with site staff.
“There seems to be a natural tension we picked up on in the study,” says Getz. “Patients and the public have a desire for options, but there is a need to balance options with the need for personal connections. Decentralized and hybrid trials offer convenience, but that convenience must be balanced with individual preferences. We are entering an age of more personalized and customized participant experiences, and we have to figure out how to manage that.”
Sites Have A Sacred Relationship
Getz notes the relationship between the patient and the clinical site is sacred, and that relationship is important to study recruitment and retention. There is a comfort level that exists between the site and patients, which enables the site to understand patients and make accommodations that are appropriate for each patient. With a hybrid trial, sites can offer alternate mediums of interaction for each study participant. Although that may be convenient for patients, Getz believes this juggling hybrid options will present challenges for sites as they move along the learning curve.
“A hybrid approach will allow sponsor companies to collect clinical research data and to offer more participation options for patients,” says Getz. “But offering more options for patients will require study staff to accommodate and execute multiple models simultaneously. That will present challenges and opportunities moving forward.”
Data privacy is another area that is very important to patients. Researchers are collecting more genetic and biomarker information in trials and relying more on personal health information and electronic medical information. In North America, 60% of patients expressed concerns over data privacy, but that does not appear to interfere with their willingness to participate in trials. Although patients seem to have a high comfort level with sharing data, approximately 20% of patients interviewed indicated data privacy is a major barrier to their participation in trials.
“When it comes to remote and virtual trial models, data privacy concerns become elevated,” states Getz. “There is a sense that as we use more technology, we may have to address a different set of expectations. Patients are also concerned that an increased use of technologies would increase their out-of-pocket costs, especially if the trial involved the use of a handheld device or mobile app. There is a lot of communicating and educating that we have to provide as we transition to more remote and virtual support in our studies.”