CER Daily Newsfeed

US FDA's RWE Efforts Gain ‘Focal Point' With New CDER Center

(12/16, Bridget Silverman, Pink Sheet) reports “...‘Given the increasing use of RWD, a centralized structure in CDER can inform operations and strategic planning, outreach and engagement, research initiatives, and knowledge management,’ the FDA said. The agency said substantial increases in the ‘volume and complexity’ of data, complicated by ‘enhanced computing power, emerging technologies, and advances in epidemiological and statistical methods,’ necessitated a centralized RWD structure.” Subscription Required

‘Haven’t We Always Done This?’ Greg Merritt’s Journey to Normalize Patient Partnership in National-Scale Research

(12/17, PCORnet Blog) comments “When Greg Merritt, a Patient Partner on the PCORnet® Steering Committee, first learned about the ADAPTABLE study in 2016, he was stunned. As a heart attack survivor who had been taking aspirin since 2012, he couldn’t believe that researchers were just now launching a study of 15,000 participants to determine optimal aspirin dosage for secondary prevention of heart attacks and strokes. ‘Don’t we already know this?’ Greg wondered...The reality surprised him. Without networks like PCORnet®, conducting research at a national scale is enormously challenging. ‘I had no idea that enrolling 15,000 patients was a big deal...I just assumed this was how research was always done when it came to questions that affect millions of people.’” Full

Most Glaring Problem in the Inflation Reduction Act

(12/16, Kirsten Axelsen, RealClearHealth) comments “...Price controls in any industry result in less supply of the item being price-controlled. So, the IRA‘s Medicare Drug Price ‘Negotiation’ Program might have been a sensible policy if the price intervention was focused on wasteful or useless medicines. But it isn’t; price controls can target some of the most valuable drugs. By doing so the policy will reduce investment in clinical development of drugs most likely to be price controlled. But, in a new year with a new administration, there are opportunities to fix some of the most significant flaws in the IRA.” Full

Enhancing Design And Implementation Of ACO REACH’s Equity-Focused And Beneficiary Engagement Design Elements

(12/17, Rachel Bonesteel, Sara Debab, William K. Bleser, Frank McStay, Robert S. Saunders, Health Affairs Forefront) comments “...In this Forefront article, we build on the limited prior research on the redesigned program—as we described in a recent piece on core payment model design elements—and provide recommendations for the Centers for Medicare and Medicaid Services (CMS) to improve the design and implementation of ACO REACH’s equity-focused and beneficiary engagement model elements.” Full