CER Daily Newsfeed

Video: How the Line Between Clinical Data and Real-World Evidence Is Blurring

(6/12, Raj Indupuri, Andy Studna, Applied Clinical Trials) “In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why organizations that build infrastructure capable of harmonizing clinical and real-world data in real time will be best positioned for the continuous, data-driven regulatory environment now emerging.” View Video

The Spine Surgery Questions 600,000 Patients May Finally Answer

(6/11, Sophie Eydis, Becker’s Spine Review) reports “...The American Spine Registry recently expanded its use of surgeon-completed clinical forms that capture detailed information about patient pathology, surgical indications and procedural decision-making. Unlike billing codes, which often provide only a partial picture of why a procedure was performed, these forms reflect the surgeon’s actual clinical reasoning. The goal is to move beyond simple outcome tracking and toward comparative effectiveness research.” Full

'Significant Number of Applications' For GENEROUS MFN Model Arrive Despite Questions

(6/11, Maaisha Osman, Cathy Kelly, Pink Sheet) reports “...Sources also told the Pink Sheet that drug manufacturers beyond the initial 17 companies that joined the Trump Administration's MFN pricing initiative were negotiating agreements with states to participate in GENEROUS (Generating Cost Reductions For US Medicaid). The comments suggest the administration's pricing initiative may be gaining traction among some manufacturers despite skepticism within the biotechnology industry...But a mid-sized industry source told the Pink Sheet they are not aware of significant interest among mid-sized companies in pursuing agreements under the framework. Many are taking a wait-and-see approach.” Subscription Required