Decentralized clinical trials, studies that allow patients to be monitored at their home leisure through modern digital health technologies, have been around with modest popularity for some time now. As with many things, the COVID-19 pandemic was a catalyst for making these types of trials, also, often referred to as virtual clinical trials, of premier importance. For example, during the pandemic, the FDA promptly announced guidelines stating trials should be switched, if possible, to a virtual model to continue research (1). Pharmaceutical companies and clinics previously hesitant to this idea were forced to step out of their comfort zones. And of course, while clinical trial design will never be a “one size fits all” for all participants and companies, the significant benefits accompanying virtual clinical trials are now coming to light.
Benefiting Both Patients and Sponsors
Virtual clinical trials are best suited for chronic diseases and studies that have fewer on-site observational requirements, such as dermatology, immunological, respiratory, gastrointestinal, and cardiovascular diseases (2). In these spaces, virtual clinical trials have a plethora of benefits compared to the standard approach, including but not limited to improved cost-effectiveness, patient recruitment, and data collection (2). While these benefits are obvious advantages for sponsors, they are also of great benefit for the patients themselves. Too often the patients involved in clinical trials do not receive the gratitude they deserve for advancing science and medicine. Therefore, it is about time we are able to offer virtual clinical trials to benefit trial participants.
Bringing Accessibility to Patients
In conversation with Gareth Powell, business development officer for the National Institute for Health Research (NIHR) Clinical Research Network (CRN), the benefits of virtual clinical trials from a patient’s standpoint were evidently highlighted. He stated that the success of a clinical trial all comes down to “accessibility”. Virtual clinical trials reduce patient burden (i.e. less site visits, no parking or transportation fees, no additional childcare or time off of work). Instead, patients can report their symptoms at their leisure, through methods such as recording in an eDiary. When clinician follow up is required, participants can engage in telehealth communication or have home visits. These benefits encourage more patient recruitment in clinical trials, allowing for improved recruitment of patients from lower socioeconomic status and underrepresented minorities. In addition, virtual clinical trials enhance data sharing, which allows participants to finally get the opportunity, if desired, to follow a clinical trial. This allows patients to see the benefit of a specific therapeutic agent or medical device and visualize the impact their participation is making to medicine and their relevant communities.
Enhancing Trial Recruitment and Data Collection
As mentioned, the scientific community benefits greatly from enhanced patient recruitment and data collection. A decentralized location removes geographical barriers, thereby providing a more diverse population. Furthermore, participants are empowered by their ability to gain and to share information when it is convenient for them versus when they are at the clinic. Also, virtual patient entries are not limited to the linear analysis done at the clinic, allowing research teams to gain data on quality of life.
Increasing Patients’ Involvement Means Improving Trial Design
While virtual clinical trials are overall providing significant benefits for patients, there are still a few kinks being actively optimized. For example, patient involvement in clinical trial design was slowly becoming a standard pre-pandemic, but the challenges of COVID-19 have made companies rethink how to continue patient advocacy conversations and community outreach remotely. These conversations are key for trial success, as this is the opportunity volunteers and patients can learn more about clinical trials and provide a platform for them to communicate if the trial protocol would work for their lifestyles. This interaction can significantly improve study design and delivery, which ultimately results in enhanced recruitment, retention, engagement, and protocol adherence (3). Other examples of challenges may include access to and ability to use technology and dislike of home visits. It is therefore important for participants to raise these concerns so that clinical trials can be designed to best suit them.
Virtual clinical trials provide many benefits to trial participants. Giving patients more power and access to their healthcare options strengthens their engagement and interest in a given trial, which ultimately enhances the quality of the study.
About the author:
Lindsay Gurska is a Cell Biology PhD trainee at Albert Einstein College of Medicine. She is interested in pursuing a career in science communication. Her current interest is in writing and creating promotional content for the therapeutic landscape.