CER Daily Newsfeed

Podcast: ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist

(1/29, Andy Studna, Applied Clinical Trials: ACT Brief) comments “In today’s ACT Brief, we look at how real-world evidence is reshaping trial design rather than replacing trials, what Worldwide Clinical Trials’ acquisition of Catalyst Clinical Research signals for oncology-focused CRO models, and new data showing feasibility and enrollment challenges remain stubborn across global trials.” Full

Real-World Data Reveals Gap Between Guidelines and Practice in HER2+ 

(1/29, Cleveland Clinic: Consult QD) comments “The standard of care for HER2+ metastatic breast cancer is taxane, trastuzumab and pertuzumab (THP), followed by maintenance therapy, but many patients don’t receive this guideline-recommended first-line treatment. Now a new study by Cleveland Clinic researchers sheds light on how often patients receive alternative therapies, and why.” Full

Oz, Other Officials Meet with Key Senators to Push Trump’s Ideas for Lower Drug Prices

(1/29, Daniel Payne, STAT+) reports “...[CMS] Administrator Mehmet Oz, Medicare Director Chris Klomp, and Theo Merkel, special assistant to the president for domestic policy, discussed with Senate Republicans how they might codify the most-favored nation drug price plan into law, according to a person with direct knowledge of the meeting...Some Republicans appeared skeptical of the proposals, the person said, which many conservatives have previously shrugged off as government price controls interfering in the free market — but the tone of the meeting was fairly neutral.” Subscription Required

Medicare Prior Authorizations off to a Rocky Start, Providers Say

(1/29, Bridget Early, Modern Healthcare) reports “...Under WISeR, vendors use artificial intelligence, machine learning and other technologies to review prior authorization requests for a limited set of procedures in six states through 2031. The agency touts the initiative as a means to reduce waste, fraud and abuse and predicts it will save $3 billion. Providers report communication gaps and difficulty completing the prior authorization process, which were among the concerns industry groups expressed about when CMS announced the program in June.” Subscription Required

Modeling Caregiver Quality of Life in HTA: Why Economic Models Struggle to Reflect Lived Experience

(1/29, Katie McCool, The Evidence Base) reports “An ISPOR Europe 2025 panel examined how caregiver health-related quality of life (HRQoL) should be incorporated into health technology assessment (HTA) economic evaluation, exploring why traditional methods can produce the “caregiver QALY trap” and whether emerging approaches better reflect caregivers’ lived experience while remaining usable for decision-makers.” Full