Contributed Commentary by Ed Ikeguchi

January 11, 2021 | Growth in decentralized clinical trials and an increasingly impressive list of features and functionality associated with remote patient monitoring and engagement technologies are making the promises of so-called Virtual Clinical Trials closer to reality than ever. But should Virtual Trials mean siteless trials? Removing sites from the equation, on paper, seems like a win, leading to lower costs and more convenience. However, with patient compliance still posing a significant challenge for sponsors, removing the personal connection and accountability checks provided by site teams can place the entire study in jeopardy.

Relationships between patients and site teams matter, but technology that helps site teams keep track of patients and engage with them quickly and easily can reduce burden on both sites and patients. Augmented by the right technology, studies can run more efficiently while enjoying higher rates of patient retention, and patients can feel connected and empowered to perform their roles independently while retaining an always-open channel for them to reach out to their site team. There’s a balance to be achieved between deploying technology that helps make drug development less costly, burdensome, and wasteful, while also recognizing the role these key stakeholders have in maintaining quality and ensuring patients stay engaged.

Find the Right Sites

Clinical trial sites that embrace new and evolving technologies are key to making Virtual Trials work. Not all sites are equipped or have a tech-savvy mindset to lean on technologies to help improve patient engagement and data collection. Sites that understand how remote engagement and monitoring technology can build on the foundation of trust between caregivers and patients go a long way in helping to run faster trials that produce better data. Tasks such as collecting patient histories can be done virtually either through real-time applications or via remote visits (tele-visits or video conferencing). Simple-to-use smartphone applications or wearable devices can be deployed to  activate continuous feeds of patient data and real-time understanding of a patient’s response to treatment. With sites accustomed to these kinds of technologies, sponsors can start studies more quickly, shorten trial timelines, and have confidence that the patients managed by these sites will perform well.

Optimize the Sites’ Role

Employing remote technology can allow sites to work more efficiently and effectively, augmenting their many responsibilities. For instance, it allows the study clinicians to focus their efforts on patient engagement and support instead of data aggregation or reporting. Traditional studies utilize intermittent in-person clinical visits to gather patient data and understand a patient’s experience in-between visits. This approach is time-consuming, tedious for both patients and site teams, and leaves room for errors and incomplete data as few patients record their study activity perfectly with even highly motivated study participants suffering from incomplete recall. Remote monitoring technologies that provide real-time data for activities such as dosing can be used to remove much of the memory burden from patients. Having a complete record of patient performance data means that site clinicians can focus patient facetime on providing specific support and strengthening relationships.

This personal connection is critical and cannot be replicated with even the most advanced technologies. It is common for patients to be anxious and uncertain about facets of a research trial, or even the trial itself. When this happens, a “siteless” trial might employ phone banks staffed by CRO employees or contracted phone interviewers to reach out to patients and probe for issues. While the intentions are good, many patients are left feeling cold and uncared for by this approach. On the flip side, when a study site physician or nurse reaches out, patients feel less like a number and more like a true collaborator in the study.

The Sponsor-Site Relationship Matters Too

There is a strong business case for keeping sites involved in Virtual Trials, aside from the data and patient engagement benefits. Physicians are a key target for selling a new therapy following the trial. While all the successful safety and efficacy data produced by the clinical study will be useful in selling and marketing the new treatment, there is no more powerful tool for selling to physicians than referrals from other physicians. First-hand experience with the new therapy gives trial clinicians expert insight into how the drug can benefit patients. Sponsors that can combine physician testimonials with accurate data collected via virtual and remote technologies give their therapy an immediate advantage over competing treatments.

The value of the connection between patients and their site-based study teams cannot be overstated. While Virtual Trials can help sponsors develop new therapies more cost-effectively and efficiently, complete removal of trial sites should not be viewed as a given. While this may be a good option for simple studies, most trials will continue to benefit when site clinicians are able to build strong relationships with patients. Research patients are under a great deal of stress, and they need to be able to trust their caregivers. Without this trust, patient compliance to the care plan, as well as their sustained participation in the study are at risk. By partnering innovative approaches and technologies with tech-savvy sites, sponsors can run trials with more engaged patients, resulting in better data.

Edward F. Ikeguchi, M.D. is the Chief Executive Officer at AiCure. Prior to joining AiCure, he was previously a co-founder and Chief Medical Officer at Medidata for nearly a decade, where he also served on their board of directors. Dr. Ikeguchi served as assistant professor of clinical urology at Columbia University, where he has experience using healthcare technology solutions as a clinical investigator in numerous trials sponsored by both the commercial industry and the National Institutes of Health. Dr. Ikeguchi holds a B.S. in chemistry from Fordham University and a M.D. from Columbia University's College of Physicians & Surgeons, where he also completed his surgical internship, subspecialty training and fellowship. He can be reached at ed.ikeguchi@aicure.com