We all know that a patient-centric approach to clinical trials generally leads to higher compliance and retention rates. Decentralized clinical trials (DCTs) are intended to be more convenient for participants than traditional site-based studies—an important step toward Patient-Centric Clinical Trials. However, patient-friendliness is not a foregone conclusion in virtual trials. Participants still need to feel looked after from beginning to end.
For certain high-risk trials, face-to-face patient contact may be essential to ensuring safety and adherence. Yet in-person encounters aren’t the only way to humanize a study. Incorporating built-in patient support can close the distance between researchers and participants—achieving the trial’s objectives while offering crucial support.
Decentralization enables Clinical Research Organizations (CROs) to conduct studies remotely from anywhere. Eliminating geographic boundaries helps CROs to recruit a more diverse patient pool, expanding access to new therapies for patients who otherwise could not participate.
Reduced travel requirements can be particularly helpful for patients immobilized due to age, medical conditions or lack of transportation options. Virtual trials can also engage participants who have restrictive family or job responsibilities, live in rural areas far from clinics or have rare diseases with small, geographically dispersed patient populations.
Hybrid trials do necessitate patients to leave their homes to visit health care professionals for blood draws, tests or other interventions, but can nonetheless lighten the patient load by enabling them to report from home for at least some of the requirements of the trial.
As with traditional or site-based trials, virtual trials require experienced clinical study teams to support participants. Making trials more convenient and accessible from home shouldn’t mean leaving participants to fend for themselves. It’s imperative to have a responsive team on the other side of the screen to humanize virtual trials and keep patients engaged.
The ObvioHealth approach to patient support in a decentralized clinical trial setting is a good illustration of how to ensure the ongoing patient engagement necessary for study success. Their Clinical Oversight And Coordination Hub (COACH) team is involved at every step of the participant journey, from prescreening through the study’s conclusion. Patients download the ObvioHealth app to enroll and log their participation throughout the process. The COACH team answers questions, addresses any concerns and monitors compliance throughout the study.
Participants and team members communicate through the ObvioHealth app’s chat platform, email and phone, giving patients access to the information they need, when they need it—but also giving them the option for autonomy when no issues arise. Some what surprisingly, the norm tends to be more rather than less communication. The company’s past four trials had 100 percent of the 367 participants chatting with ObvioHealth’s team.
Interestingly, the bulk of these chats are not linked to the need for tech support. More often, patients have questions about the study product, compliance, health conditions or the overall study process. Below are real examples of questions from trial participants that the COACH team has responded to:
· I’ve been experiencing constipation. Is it OK to stop the [study product]?
· I missed using my [study product] for three days. Can I still continue in the study?
· When will I receive my [study product]?
· Why did I get a notice of ineligibility?
· I had my labs done yesterday. How do I get a copy?
Sometimes, participants just need to feel a human connection. Throughout the COVID-19 pandemic, many participants have been reluctant to travel to traditional study sites, like doctors’ offices. Others, such as participants in mental health virtual clinical trials, may have conditions that make face-to-face interaction uncomfortable.
“Many patients feel isolated from the world, which can take atoll on them,” says ObvioHealth Medical Director Dr. Parth Shah. “Participants want to talk about their lives, and it brightens their day to speak with the study team. They appreciate this remote engagement.”
The ease of communication in a virtual study often translates to higher engagement and better data collection. “With a virtual site team, interactions with the study coordinators are more convenient,” Dr. Shah says. “People don’t remember all their questions when they’re meeting face-to-face with the doctor every few weeks. Instead, they can send a message to the team when it’s top of mind.”
Participants can also raise concerns about side effects or drug interactions without needing to call the doctor’s office, leave a message and wait for a return call. Getting timely answers can help ensure compliance with the study protocol. The real time capture and transmission of data can also help coordinators detect adverse events more rapidly.
Participants are asked to regularly report any changes in their health status. The beauty of ePRO (electronic patient reported outcomes) is that as soon as the system registers a “yes” response to a health status change, the virtual site team is alerted and can follow up in near real time. For instance, if the participant indicates they are having a headache, the study can be programmed to probe the severity, and if the responses indicate a potential issue, the team will know to intervene as needed.
Successful execution of a hybrid or completely virtual trial requires a clear strategy and an engaged team. This begins at the design phase with a patient-centric protocol and study flow that anticipates the needs of every team member, both participants and coordinators. Study team members must understand and internalize the participant-facing experience with the app and the technical aspects of the back-end system in order to be able to run the study from start to finish, troubleshooting as needed.
For example, a virtual trial will typically include automated participant-facing notifications that remind them about upcoming labs. These reminders reduce the team’s workload and help manage a large patient population efficiently. At the same time, the platform can alert the team about the upcoming labs and suggest that they send a text asking if participants need any help with the process. These human touch points help participants and study teams build a stronger rapport and lead to a greater sense of engagement throughout the study process.
On the back end, there are also real benefits to virtualizing trials. Traditional site-based studies are often siloed, with data aggregation occurring toward the end of the study. But with a virtual trial, ePRO and device data flows centrally to the study team, giving both them and sponsors a 30,000-foot view of the study’s progress in real time. Continuous and point-in-time data can be streamlined and clearly displayed on a dashboard that provides a view across the entire patient pool. This can help teams detect patterns more easily and ultimately lead to more efficient decision-making.
“Our team is there to make sure that this platform is delivering on the needs of the study,” says Dr. Shah. “We’re constantly looking at the data, communicating with participants and feeding input to the design team about anything that needs improvement. We’re involved at every level of the study, which means we’re very invested in its success.”
It is relatively unique within the world of virtual clinical trials to have the team who has designed the DCT platform available to service the study end to end. But ObvioHealth’s model is to create a positively reinforcing circle, in which study team experience can serve as inputs into an optimized platform and the COACH teams’ platform expertise can improve the participant and sponsor experience.
The future of decentralized trials is bright, according to a PwC Health Research Institute report that says 93 percent of pharmaceutical and life sciences executives see virtual trials as important to their company’s pipeline in the next five years. “The decentralized trial model offers additional opportunities to disrupt the trial ecosystem and gain efficiencies through simplification of the trial drug supply chain, reduction of clinical research associate visits, and increased uses of data and analytics for trial oversight,” the report states.
Engaging with a robust virtual site team, such as ObvioHealth’s COACH, allows sponsors to progress more efficiently and can often reduce costs substantially. The key is to work with an experienced team that can tailor the protocol to the sponsor’s goals and the participants’ needs.
“For decentralized trials to work, the technology needs to be designed for real interactions with real people, in real time,” says Dr. Shah. “Having an experienced, hands-on team gives us the ability to make studies more accessible, more engaging and ultimately more effective.”