“Google announced this week that it will make the U.S. Food & Drug Administration’s open-source MyStudies platform available on the Google Cloud Platform.”
“WHY IT MATTERS
The goal, said Jameson Rogers, product manager at Google Cloud Healthcare & Life Sciences, is “stimulate an open ecosystem that will improve the ability of organizations to perform research that leads to better patient outcomes.
FDA’s ongoing prioritization of real-world evidence means that “drug and device organizations are increasingly looking to incorporate patient-generated data into regulatory submissions for new products and treatment indications,” as Rogers explained in a blog post…”
“THE LARGER TREND
As part of the initiative, Google will bring MyHeart Counts, a cardiovascular research study run by Stanford University, onto the FDA’s platform. So far, that project has enrolled more than 60,000 participants and enabled deeper understanding of the feasibility of conducting large-scale, smartphone-based clinical trials, Rogers notes.
“Once enrolled, participants are asked survey questions related to their health and physical activity,” he explained. “Participants may allow MyHeart Counts to collect physical activity data from their phone and other wearable devices. If participants are physically able, they will be asked to perform a 6-minute walk test, then enter information about risk factors and blood tests, which is used to determine a cardiovascular risk score.”
Until now…” Read the full article here.
Source: FDA real-world evidence to be made available on Google Cloud – By Mike Miliard, January 8, 2020. HealthcareITNews.
