By Benjamin Ross  

November 2, 2016 | With Fitbits, iPhones, and other handheld tech becoming more and more accessible, the task of gathering data for clinical trials has also become more efficient. Litmus Health, a data science platform measuring health-related quality of life, recently launched into public beta at the University of Chicago. Their goal? Make the entire world one big clinical trial.

That aspiration was spelled out by Daphne Kis, one of Austin, Texas-based Litmus Health’s co-founders. Along with Sam Volchenboum and Josh Jones-Dilworth, Kis founded Litmus in 2014. Kis comes from an entrepreneurial background, having spent the last twenty years as co-founder and CEO of EDventure Holdings. VP of engineering James Crooks rounds out the Litmus team.

“We’re going to market early clinical trials and are integrating clinical trial data with active and passive sensors, [and] mobile device data to help researchers in Phase I and II of their trials to get better data on quality of life,” Kis told Clinical Informatics News.

The Litmus platform supports more than 200 data sources that describe patients’ behavior and environments including Fitbits, iPhones, Jawbone products, and any FDA approved device. The company also draws from a library of validated patient surveys. Researchers are able to customize their data sources and build their unique trial, combining traditional validated surveys with patient-generated remote data to capture a comprehensive indication of a patient’s health and quality of life at any point in time. Once data is collected, Litmus uses machine learning and other algorithms to align time series data, integrate multiple orthogonal data sources, and look for correlations between behavior, environment, and patient outcomes.

The public beta pilot is underway with the cooperation with the University of Chicago in a clinical trial focusing on Crohn’s disease. (Volchenboum is a member of the University of Chicago faculty, running the research informatics group for the university as a pediatric oncologist.) The trial is using Fitbits distributed by the research team to over 100 patients, who will be using the device for the collection of passive data, such as sleep data and heart data. The project is funded by Takeda, and is being managed by gastroenterologist David Rubin.

A huge part of this platform is taking advantage of the seemingly limitless access we have to handheld devices, such as smartphones and Fitbits. “Part of it is that these devices are out there and people who have chronic conditions are trying to capture this data all the time… People keep it in some diary form or in their heads,” Kis said. “Here we have a chance to bring this together in the trial context, so it’s a matter of integrating these things together in a way that makes the data meaningful to researchers, and, of course, ultimately to patients.”

Volchenboum saw great potential in the integration of these common devices, having observed a certain amount of frustration among colleagues of his who were conducting clinical trials over the past few years. “There are people in the clinical trial division who waste a ton of money during Phase I and Phase II of trials, waiting for data to come back,” he told Clinical Informatics News. “And when the data does come back, [the data collectors] are suspicious because the data is collected in archaic ways. And then they use that data to decide whether they are going to move from Phase II to Phase III, which is very expensive.”

Much of the data fueling clinical trials relies on the memory of the participants. How many hours of sleep did I get last week? On what specific days did I feel bad last week? Questions like these are hard to answer sometimes, but the answers are critical to clinical trials, especially in the early phases. The data collected provide researchers with insight into whether or not they should proceed into Phase III. “We think there’s a real opportunity here to help researchers make better go/no-go decisions earlier in the process,” said Kis.

Kis and Volchenboum are both committed to progressing their new platform on a global scale, though Kis’s “entire world” goal is still far down the road. Currently, Litmus Health sells a license for their platform to interested clinical trials, as well as a per user fee on top of that, and is focusing on building a reputation within the clinical trials community.

“Our intent is to apply discipline in the near-term to really earn the right to pursue [future partnerships],” said Kis. “[Our near future plans involve] getting more relationships, and growing our team. It doesn’t take long before you end up with a very large and meaningful amount of data.”

“For us it’s all about trying to find a way to validate the platform… We’re really intent on inflammatory diseases because we know that’s a population that loves to track their systems and I think that it’s something where people have already seen correlations between what they do and how they feel,” said Volchenboum. “It’s a really exciting phase for us.”