News from Thursday, September 11, 2025
Articles
National Pharmaceutical Council Study Reveals Post-Approval Oncology Trials Fall after Inflation Reduction Act, with Disproportionate Effect on Small Molecules
(9/11, Katie McCool, The Evidence Base) reports “...The authors used a difference-in-difference analysis to separate the impact of this policy from other influences, such as the pandemic. As Dr Patterson, Senior Director of Research at the NPC, explained: ‘We used the trend of biologics as the control to estimate the impact of the shorter DPNP eligibility timeline on initiation of post-approval clinical trials among oncology small molecules. The significant additional decline of nearly five fewer small molecule trials a month suggests that we're already observing the impact of the pill penalty in small molecule cancer research.’ Dr Zheng, lead author and NPC Research Manager, noted the importance of small molecule drugs for patients: ‘In addition to the therapeutic benefits, small molecule drugs often provide greater flexibility and convenience for patients, making cancer treatments possible through a pill taken at home. We sought to quantify the impact of their shorter ‘clock' to government price regulation on post-approval clinical trials for oncology.’” Full
Real-World Data Show Tirzepatide Benefit in Type 1 Diabetes
(9/11, Miriam E. Tucker, Medscape) reports “Tirzepatide produced significant weight loss, reduced insulin requirements, and improved glucose control without increasing hypoglycemia when used off-label in adults with type 1 diabetes (T1D), new observational data showed.” Full
ACO REACH 2023 Performance Results Indicate A Pathway To Sustainable Accountable Care
(9/11, Kylie Brown, Rachel Bonesteel, Sara Debab, Frank McStay, Robert S. Saunders, Health Affairs Forefront) comments “...In this analysis, which builds on two previous reports from the authors on opportunities to strengthen the model, we synthesize what these two evidence streams tell us about model progress, highlight areas of alignment and tension between performance metrics and evaluation findings, and identify policy considerations to support ongoing implementation. We draw on performance data, evaluation results, interviews with participants and stakeholders, and prior work engaging ACO REACH participants and experts to identify opportunities for CMS to enhance transparency, support uptake of population-based payments, and continue advancing equity within the ACO framework.” Full
Press Releases
Bassett Research Institute Awarded Funding for National, Multi-Center Clinical Trial
(9/10, Bassett Healthcare Network Press Release) “Bassett Research Institute has been awarded research funding of approximately $12 million from the Patient-Centered Outcomes Research Institute (PCORI) to launch a study about the effects on the kidneys of a common antibiotic regimen used to treat hospitalized patients with severe infections. Conducted in real-world care settings, the study will generate evidence on outcomes that matter most to patients, helping them and their clinicians make better-informed decisions.” Full
Journals
Comparative Effectiveness and Safety of Probiotics with Psychotropic Potential in Mental Health Benefits in Irritable Bowel Syndrome: A Systematic Review and Network Meta-Analysis
Theodore Rokkas, et al.
August 25, 2025, European Journal of Gastroenterology & Hepatology
Effect of Aficamten Compared With Metoprolol on Echocardiographic Measures in Symptomatic Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM
Sheila M Hegde, et al.
August 27, 2025, Journal of the American College of Cardiology
A Learning Health Care Community: Integrating Research and Practice at Scale
Leif I. Solberg, MD, et al.
September 2025, The American Journal of Managed Care
Comparative Effectiveness and Safety of Second-line Therapies and Dosing Regimens for Advanced Hepatocellular Carcinoma: A Network Meta-Analysis
Xinming Lei, et al.
September 10, 2025, European Journal of Gastroenterology & Hepatology
Expert Perspectives on Next Generation Health Guidelines: How to Integrate RWE in EBM
Del Giacco S, et al.
September 11, 2025, Pragmatic and Observational Research
Pragmatic and Observational Research
Comparative Effectiveness of TAVI Platforms and Surgical Aortic Valve Replacement: A Network Meta-Analysis of Randomized Controlled Trials
Francesco Moroni, et al.
September 11, 2025, Circulation: Cardiovascular Interventions