CER Daily Newsfeed

Large Breast Cancer Screening Trial Will Be Pivotal Step in Vetting AI for Mammograms

(9/24, Katie Palmer, STAT+) reports “...‘Companies are pushing hard to incorporate AI into practice,’ said Diana Miglioretti, co-lead of the U.S. Breast Cancer Surveillance Consortium, who will lead the trial’s data coordinating center at UC Davis Health. But most evidence for the tools is based on ‘artificial settings,’ she said, where results don’t impact women directly. So the two-year trial, supported by the Patient-Centered Outcomes Research Institute, will seek to answer critical questions about whether AI deployed in the U.S. results in meaningful changes in breast cancer detection and patient callback rates in the real world.” Subscription Required

FDA Publishes New Landscape Analysis of Real-World Evidence in Regulatory Decision-Making

(9/24, Joanne Walker, The Evidence Base) reports “...The webpage consolidates more than a decade of case studies, dating back to 2011, where RWE played a role in determinations ranging from product approvals to regulatory assessments that concluded no action was necessary. Through these examples, the FDA is signaling both the growing relevance of RWE in regulatory science and its commitment to making decision-making processes more visible to stakeholders, including industry, healthcare providers, and patients.” Full

Big Pharma's Backlash Against England Continues as Lilly CEO Ricks Blasts Country on Drug Pricing, Investment

(9/24, Kevin Dunleavy, Fierce Pharma) reports “...[Eli Lilly CEO David Ricks] pointed out that the U.K. pays less for drugs than other developed countries. He also suggested that the often hard line drawn by England’s National Institute for Health and Care Excellence (NICE) in pricing assessments could compel companies to stop selling their drugs there. ‘Unless that changes, I don’t think they will see many new medicines and I don’t think they will see much investment,’ Ricks said. ‘That’s the U.K.’s choice, but we react to those choices.’” Full