How Tech and Data Enable Patient-Centric Clinical Trials

Recruiting is one of the most costly and challenging aspects of clinical research. Less than 5 percent[i] of patients currently participate in clinical research, largely because they find participation overly burdensome. Frequent site visits, time and cost of travel, and the impact of these trips on families and caregivers are regularly cited for opting out of trial participation-or dropping out[ii]. 

It’s a bleak picture when you look at the numbers alone but as an industry we are at the beginning of a transformational scientific renaissance that could reverse that. Recent advances in clinical technologies, including wearable devices, teleconferencing, advanced analytics, and cloud technology platforms, could lower trial burdens and the bar for participation.

Remote or virtual trials are ground-breaking, offering significant advances in innovation and patient benefit for sites and sponsors. This model promises to transform the way clinical trials are conducted and to leverage technology to make the trial experience easier and more engaging for the patient.

Trial engagement and treatment occurs from the patient’s home while the principal investigator interacts remotely. Patients meet with physicians or other trial staff via teleconference, complete questionnaires online, receive medication directly to their home, and transmit data via wireless wearable devices. By providing guidance, treatments and support, these professionals work to ensure the patient understands and is aligned with treatment goals. Patients can also receive support from nurses and phlebotomists to supplement and enrich the study.

The model is compelling because it puts the patient at the center, compared to traditional site-based clinical trials where patient focus is often secondary. 

The obvious benefit of virtual trials for patients is reduction in need to travel. Participating in study visits from home eases the patient burden and allows investigators to interact with more patients and be more productive.

However, the benefits of virtual engagement extend well beyond lowering burden. With improved study execution and new data sources patients become more connected to the research. For example, apps and sensors on medication packaging can send patients reminders if they fail to complete treatment steps or surveys, and remote site staff can be prompted to check on patients who miss appointments or medication doses, or if data from a wearable device suggests they are distressed. 

Wearables offer far richer data and study insights available to investigators than they typically collect in a site-based trial. Rather than relying on patients’ reports, wearable devices transmit a stream of data points in real time to provide a full and unbiased view of the patient’s condition. Investigators can also tie external information into the research-such as environmental conditions-to add context to the data.

Ultimately attrition is reduced as patients feel more engaged in the research process.

The FDA is increasingly requiring more patient diversity in pre- and post-marketing studies, reflecting the fact that ‘medical products are safer and more effective for everyone when clinical research includes diverse populations.[iii] Virtual trials encourage diversity. With more innovative and direct paths to individuals, taking trials directly to them, diverse and geographically distant patients are more likely to participate in a study. 

The industry has already successfully seen virtual trials in such disease categories as diabetes, central nervous system conditions, dermatology, and others. If patient safety can be confidently maintained and high-quality data can be collected remotely, then a virtual trial can work. Long-term extension trials for complex disease categories will fit the virtual trial environment if patients are stable and treatments are appropriate. In cases where patients need a few on-site visits, hybrid models can be deployed. 

In 2016, Sanofi completed a totally virtual Phase IV diabetes trial, called VERKKO[iv], which included 60 patients recruited through Facebook. The results exceeded expectations, with an 81 percent conversion rate among patients who showed interest in participating and a less than 10 percent dropout rate.

And in 2016, IQVIA led a virtual trial pilot to study remote detection of Alzheimer’s disease[v]. Investigators used a telehealth platform to conduct endpoint validation in prodromal patients, comparing the quality of endpoint data collected remotely to standard in-person encounters. The remote model had faster recruitment and demonstrated economic, scientific, and social benefits. 

While the underlying technology that supports virtual trials isn’t new, what is unique and different is how these technologies are assembled and applied to the clinical trial setting. Sponsors and regulators are beginning to see these unique benefits that will ultimately lead to rapid adoption of virtual trials. By accelerating recruitment efforts, improving retention rates and realizing a more diverse patient population, virtual trials will fundamentally transformthe clinical research landscape in the years to come.

 

[i]E. Miseta. Clinical Leader. July 13, 2015