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Radar On Market Access: Value of Device-Gathered Data to Regulatory Agencies

Posted by Matt Breese on Jun 5, 2018

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While physicians may be the obvious stakeholder to benefit from the data gathered from wearable and handheld drug-administration devices, regulatory bodies also are realizing their value, AIS Health reported.
In recent years, both FDA and the European Medicines Agency are warming to the use of real-world evidence (RWE) during the regulatory-approval process, according to John J. Doyle, senior vice president and general manager, real-world and analytic services, IQVIA.
In August 2017, the FDA issued nonbinding recommendations, entitled The Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. It admits that data collected during clinical care or in the home setting may not have the same quality controls as data collected within a clinical trial setting, yet "under certain circumstances RWD [real-world data] may be of sufficient quality to help inform or augment FDA's understanding of the benefit-risk profile of devices at various points in their life cycle."
The FDA also recognizes the value of post-marketing data collected during use once the product is on the market already. "Aggregation of RWD (e.g., in medical device registries) may prove useful as a postmarket control suitable for providing ongoing device safety surveillance and additional evidence for effectiveness," the FDA wrote. "FDA believes that applying postmarket controls to reduce premarket data collection, when appropriate, can help improve patient access to safe and effective medical devices."  

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Topics: Industry Trends, Data & Analytics