Fully virtual clinical trial performed by Science 37
An acne clinical trial has become the first in the world to be conducted entirely through a smartphone app. AOBiome Therapeutics ran the 16-week, randomised, placebo-controlled study using Science 37’s mobile Network Oriented Research Assistant (NORA) platform. As well as halving the enrolment period, the virtual study also saw more non-white participants involved than traditionally managed trials. Science 37's NORA model is seeing use in trials exploring cancer, diabetes, liver disease and headaches.

Los Angeles-based research company Science 37 announced the completion of a clinical study for AOBiome Therapeutics conducted entirely through a smartphone app.

The Phase 2b study ran on the back of Science 37’s mobile Network Oriented Research Assistant (NORA) platform, which allows for real-time video chat, customized self-photography models, data collection, and electronic consent. Science 37 Cofounder and CEO Dr. Noah Craft said that this study marks the first time an interventional, randomized, placebo-controlled trial of this kind has been conducted completely in the virtual space.

“Over the last three years we have had great success using our ‘Metasite’ approach to complete portions of larger trials; this is the first time we have run an entire trial virtually from start to finish,” Craft, who was also the study’s principal investigator, said in a statement. “With this technology, we were able to accelerate enrollment, capture on-the-ground results as they occurred, and ensure a greater diversity of participants in this truly patient-centered study.”

Through the platform, researchers screened more than 8,000 people and enrolled 372 participants within seven months to participate in the study of AOBiome’s acne treatment. Science 37 said this is approximately half the time that would have been necessary with a standard enrollment, and also noted the increased recruitment of non-white participants compared to most studies.

“We originally estimated that the Phase 2b acne study would take significantly longer, requiring numerous clinical sites to complete,” AOBiome President Todd Krueger said in a statement. “We are proud to have innovated the study design with the Science 37 team. This is truly an industry-first and we are excited about the results of the partnership.”

Enrolled participants were loaned an iPhone and data plan, and self-administered the spray-based intervention twice a day over 12 weeks with an additional four weeks of follow-up. With their devices, participants were able to connect with investigators 24-7 without having to visit any particular study site. In their own statement, AOBiome announced positive safety and efficacy findings based on the data collected through NORA.

"The completion of the AOBiome study is a great demonstration of efficacy and the ability to scale and run entire trials remotely through Science 37's Metasite model without the need for brick-and-mortar facilities,” Craft told MobiHealthNews. “We believe that at least half of trials today can be done [virtually] with the right expertise and logistics behind them."

Currently, Science 37’s model is also being implemented in trials investigating headache, liver disease, cancer, and diabetes. Earlier this year, the company raised an additional $29 million after receiving an even greater amount in its previous round last year. It currently reports approximately $67 million in total funding.