Real World Evidence Benefits, Limits Explored In US FDA Demonstrations
FDA's Jacqueline Corrigan-Curay lists three demonstrations now underway that are aimed at looking at different aspects of generating real world evidence and may inform the agency's evaluation of the data and methods.
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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.
Real-World Data: Precertification Could Aid Use For Regulatory Decisions
Voluntary precertification process could help ensure the quality and integrity of databases from which real-world evidence is derived, but the program could be a cost burden for data curators and accreditation criteria would need to be developed, experts said at a recent Duke-Margolis Center meeting.
Real-World Evidence Challenges: Death Among Toughest Data Points To Measure
Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.