Pfizer made a big splash back in 2011 with its announcement of the first “virtual” clinical trial. This news was significant because, for the first time, patients would have the opportunity to be screened, enroll, and ultimately participate in a trial entirely via internet-connected devices — in other words, without setting foot on a clinical trial site. In an expensive industry where increased efficiency and patient convenience correlate with profits, this attracted significant (if somewhat skeptical) attention.
Some of that skepticism was warranted. According to Michal Orri, Senior Director of Clinical Sciences at Pfizer, the trial initially failed to recruit enough patients. Was this virtual, patient-centered approach a failed model? Hardly: despite the imperfect outcome of this first trial, the Pfizer study has ignited intense interest in virtualization. Today, virtual trials are increasingly common and may, in fact, revolutionize the Pharma industry.
Pfizer believes that their initial trial was unsuccessful, incidentally, because it didn’t cater enough to patients. As Outsourcing-Pharma notes, their online process was overly complicated and confusing from the outset. However, after simplifying online enrollment and adding a patient-oriented call center, the trial made appreciable enrollment gains. In fact, the FDA has since requested that they validate their final procedures for more widespread adoption.
The essential advantage of virtual trials is that they enable patients to enroll on their own terms; mobile health, e-platforms, remote monitoring devices, wearable technology, and telemedicine all make it simpler, and more inviting, for patients to consent to and participate in trials.
Clinical sponsors and CROs will have to employ digital strategies with a measured approach, ensuring that these strategies meet rigorous thresholds for cost-efficiency and usefulness. Even so, most clinical researchers are cautiously optimistic, because such tech tends to allay the skepticism of the most important group of all — the patients.