With all the recent technological approaches to clinical trials as of late, it’s clear that the notoriously long, expensive and often inefficient traditional process could use an update. From AI-powered matching platforms to increasingly sophisticated software to streamline data collection during trials, the space is getting busier.
Palo Alto-based monARC Bionetworks is one of the latest to make its presence known. The company, which was founded in late 2016, offers a digital research platform with a strong focus on patient engagement at the center of clinical trial recruitment, retention and follow-up. monARC (the last three letters stand for “Accelerating Research through Collaboration) just launched its first connected clinical trial, which will study idiopathic pulmonary fibrosis. Currently, the company is awaiting final approval for the trial’s companion, public ResearchKit app, and expects to see it on the app store sometime this week.
“monARC is a culmination of learning over our careers – and especially the last five to eight years – of how we do clinical trials,” monARC CEO and founder Komathi Stem told MobiHealthNews. “Despite how many innovations we have had, from the discovery of the genome to CRISPR and the acceleration of delivering drugs, things come screeching to a halt when they hit clinical trials. We’re still doing things the same as we were 20 years ago.”
Stem founded monARC after more than two decades in leadership and consulting roles for Genentech, Eli Lilly, Amgen and AztraZeneca. She also worked for remote clinical trial company Science37. The entire multidisciplinary team of monARC hails from drug development, clinical research, app development, data security and patient engagement, and has deep industry ties. monARC’s advisory board is made up of executives from 3M, Pear Therapeutics and Indalo Therapeutics as well as Tufts Unversity.
“There are a lot of new tech-enabled solutions out there, but they are often point solutions looking through the perspective of pharma,” Stem said. “We want to make it more collaborative, and we want to center it around the patient.”
That being said, monARC wants to make clinical trial patients feel less like customers going through a transaction and more like active participants.
“Eighty percent of trials are delayed because of enrollment. So we started out with trying to answer the question of how we can make it simple for patients to share data,” said Stem. “We want monARC to function as a data sharing economy that leverages the patients as the key gateway. We couldn’t do that five years do.”
But thanks to the proliferation of patient-facing tools like apps and connected devices – along with more robust standards for data interoperability – it’s now possible to create such a data sharing economy, Stem said. Additionally, there is plenty of room for improvement.
“The typical process of a clinical trial is highly sequential, and doesn’t engage patients til the end. At each one of those sequences in the timeline, there are failures, because every part is designed in a silo,” she said.
For example, patients are screened after the trial is designed, at which time it is discovered that they trial might not even necessarily fit with what kind of data patients can offer. This results in multiple iterations and launches of the trial, which leads to less-than-stellar outcomes: Two out of three clinical trial sites never meet their goals, Stem said, and – even after taking an average of 12 to 18 months per trial to enroll – only about five to 7 percent of qualified patients end up participating.
“monARC wants to flip it. We have an active patient research network and start with them, bringing in patients who are highly motivated. What we learn from them informs the trial design and gives us a prequalified patient population,” she said.
From there, monARC directs patients to a portal, which is serviced by a network liaison who gets patient consent and requests all medical records. monARC digitizes and consolidates records, and gives participants an app to begin generating a smart health record. Once the app is downloaded, it immediately begins passive data collection, allowing participants to continually inform trial design and efficacy.
The company, which raised seed funding last year and has strategic partnerships with Genentech, Roche and the University of Waterloo, is off to a pretty quick start. Since launching the network in January, monARC has 75 participants in their first connected clinical trial and plans to launch a second soon. With 49 molecules in their portfolio to plan trials around, Stem said the company has several pharma companies interested in working with them, along with many other stakeholders.
“At the output, we want to provide a service to researchers and providers, and payers can tap into it to do comparative trials. Because we have continuing patient engagement, we will start to have pharmacovigilance data as well,” said Stem. “We’re very passionate about data-sharing, and the patient is really the one driving our mission.”