Litmus puts clinical trial data collection to the test
November 7, 2016
Texas-based start-up Litmus Health, a clinical data science platform focused on health-related quality of life, has launched into public beta. The company uses data collected at the point of experience from wearables, smart devices and home sensors for clinical trial management.
Litmus is initially focused on phases I and II clinical trials. The decision faced by pharma to move forward from phase II to III is an expensive one, as several hundred million dollars usually hang in the balance. The goal is to get breakthrough treatments to market faster by putting health-related quality of life at the forefront of clinical development. Too often researchers press forward having collected little data on what’s happening outside the clinic and, even then, only across a few dimensions.
“The answers we need are everywhere around us,” said Samuel Volchenboum, chief science officer of Litmus, and director of the Center for Research Informatics at the University of Chicago. “We need a better way to collect data in clinical research. Smartphones, wearables, and home sensors present a unique opportunity. Most researchers understand the value of patient-generated information collected at the point of experience, but they have no good way to harness those data. The ability to measure outcomes in multiple dimensions, remotely, is key. Litmus helps research teams and their sponsors make more confident go or no-go decisions.”
The platform supports more than 200 data sources that describe patients’ behaviour and environments. The company also draws from a library of validated patient surveys and can easily add new instruments. Researchers are able to customise their data sources and build their unique trial, combining traditional validated surveys with patient-generated remote data. The result is a comprehensive indication of a patient’s health and quality of life at any point in time.
Once data are collected, Litmus uses machine learning and other algorithms to align time-series data, integrate multiple orthogonal data sources, and look for correlations between behaviour, environment and patient outcomes.
The dashboard displays data that indicate each study’s progress and surfaces population trends. Researchers can view individual participants’ data. The trial companion mobile app is available for iOS and Android. It serves as a clearing house for device data, which it gathers and sends back to the platform.
“These devices are already in the hands of consumers,” said Daphne Kis, CEO of Litmus. “The challenge is to credibly accommodate the data they collect. We have the opportunity to help researchers understand patients and their quality of life as we never have before, and the market is ready. These data are going to have huge implications for the healthcare ecosystem and for how we use patient data both in the clinical trials setting and beyond. In the not too distant future, the entire world will be one big clinical trial.”
The platform is being piloted at the University of Chicago in a clinical trial run by gastroenterologist David Rubin on the effects activity, sleep and diet on inflammatory bowel disease patients.
“We all want to collect higher quality, more accurate data from patients in our clinical trials,” said Rubin. “Litmus is the first platform I’ve seen that actually delivers.”
Litmus was founded by an interdisciplinary team of healthcare, bioinformatics and software engineering experts.
The platform meets the standards for collecting and storing data according to HIPAA regulations and is 21 CFR part 11 compliant. The data the company collects are ready for submission in CDISC’s CDash format, as mandated by the FDA.