Real-World Evidence Demo Projects From US FDA To Include New Mobile App
Agency releases open source code and technical documents for new mobile app designed to gather real-time information about medication use and patient-reported outcomes; app will be incorporated into several PCORI-funded studies that FDA is leveraging as it explores the regulatory utility of real-world data.
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Patient-Reported Data In COVID-Impacted Trials: US FDA Cautions Against Missing Data, Potential Bias
Considerations for switching from in-person to remote collection of patient- and observer-reported outcomes addressed in latest update to Q&A guidance, which also discusses Part 11 compliance requirements in the context of the pandemic and electronic collection of informed consent through MyStudies app.
ODAC's 17-18 June discussion of pediatric development plans for four investigational oncology agents will serve as a trial run of the technology platform and logistics for any future application-specific virtual advisory committee meeting, but without the stress associated with a pending application and a user fee deadline.
US FDA hopes COVID-19 may finally spur data coding changes that will make real-world evidence projects proceed faster. The pandemic is now part of five real-world data projects using FDA's Sentinel system, but some other real-world data projects are paused due to the health crisis. The private sector is also changing the way it conducts real-world data work due to COVID-19.