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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The prototype pulls information from the electronic record to fill out enrollment and other forms, but stakeholders say it must work for most, if not all, REMS drugs in order to be widely used.
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.