The Role of Clinical Study Sites in Virtual Trials
Advancements in technology have resulted in an increase in interest around Virtual Trials. Due to the COVID-19 pandemic and concerns about trial continuity as well as the ability to start new trials, many in the industry became more willing in 2020 to employ virtual approaches to patient interaction and data collection. Because of this, we as an industry have learned a great deal about what a Virtual Trial actually is. One key lesson we’ve learned is that, even with the many advanced technologies we can put to work to engage patients and collect data remotely, clinical study sites still play a critical role.
In my experience, trials always go better when there are personal relationships between patients and their care team. This is a piece of the clinical research puzzle that can’t be duplicated with approaches that are 100% virtual. At the beginning of a study, in particular, patients want to meet and talk with their doctors and nurses in person, and vice versa. Human beings are wired for three-dimensional communication. We are social beings adept at picking up on visual cues like body language and facial expressions. These can be difficult to pick up in a totally virtual environment, typically a two-dimensional computer or smart device screen. Making a point to begin patient engagement in-person helps to solidify the personal connections between patients and clinicians.
From a data collection perspective, this also allows the care team to explain the nuts and bolts of the study in detail while getting a sense of whether the patients (and family members or other caregivers) are truly understanding what will be expected of them, if they’re feeling overwhelmed and if they will need more or less support throughout the course of the study.
Once these vital face-to-face meetings have taken place and the relational foundation is set between patients and the clinical study teams, it then makes sense to employ Virtual Trial technologies to create channels for communication and engagement that are easy for patients and the study teams to use. In this way, technology can be a powerful complement to, and facilitator of, the important work being done by the sites.
Powering Sites and Empowering Patients
Remote engagement and monitoring technology are useful in reducing some of the burden of in-person visits. Patient histories can be collected virtually through remote visits and certain types of study data can be gathered remotely and shared with clinical teams in real-time. For example, remote applications can gather dosing data with high accuracy, as video technology available on today’s smartphones and similar devices can record each dose and confirm adherence. Wearable devices and electronic diaries can also be utilized to provide a constant stream of high-quality data for study teams. An additional benefit to having this real-time data is that study teams can optimize their in-person visits with patients. Many times, these visits can be spread out weeks at a time and relying solely on patient recall of their activity between visits can produce less-than-clear data. With technology at work monitoring this activity, the study teams will already have access to it when the patient is with them in the clinic. This allows them to focus on patient well-being and on providing the right level of support for each patient, strengthening the relationship which helps keep patients engaged in the study and can help with retention.
At the same time, giving patients a tool for helping to manage their own trial burden helps to keep them active and involved. Patients participating in clinical studies have a lot to deal with beyond their study responsibilities. They have work and family obligations and often have other health issues they’re dealing with besides the disease state that brought them into the study. Having a technological helper to lessen the burden of what can often be complicated treatment regimens can make a big difference with patient engagement. Additionally, having an always-open channel to the site team when support is needed is another great benefit for patients.
The connection between patients and their site-based study teams is irreplaceable. For studies to be successful, patients need to feel comfort and trust with their care providers and study teams need to understand the levels of support patients need to be successful. Virtual Trial approaches can be both effective and useful in collecting and analyzing study data, but to unlock their true potential, they should be partnered with tech-savvy sites who know how to use these tools to strengthen patient relationships.