For patient-reported adverse events to support clearer safety insights and improved outcomes, the fundamental problem of effective and consistent data capture must be solved once and for all. AI can help with this, but not in the way many think. The real opportunity is about how to get good data in, not how to make the best of poor data, and regulators could be doing more to drive this, says Daniel O’Keeffe of Qinecsa.
All pharma manufacturers and marketing authorisation holders have a duty to minimise the harm to patients that