News from Monday, May 5, 2025
Articles
Value Viewpoint: May 2, 2025
(5/2, Kimberly Westrich, LinkedIn) comments “...New research published in Therapeutic Innovation & Regulatory Science examines the prevalence of patient engagement (PE) and patient experience data (PED) in health technology assessment (HTA) and the regulatory review process. In their landscape analysis, study authors identified 28 references from HTA/regulatory bodies, 26 from peer-reviewed articles, and 8 references on PE and PED integration (PE+PED) from HTA/regulatory bodies, compared with 0 references in their previous 17-month analysis.” Full
What The EMA Can Teach HTA Bodies About Joint Clinical Assessments
(5/5, Francesca Bruce, Pink Sheet) reports “...Taking lessons from the European Medicines Agency on dealing with unconventional development pathways will help improve the new joint clinical assessment (JCA) process under the EU Health Technology Regulations and help patients access advanced therapies.” Subscription Required
Press Releases
Datavant and Boehringer Ingelheim Expand Partnership to Fuel Scalable Real-World Evidence Infrastructure
(5/5, Datavant Press Release) “...Paul Petraro, Executive Director and Head of the Real World Evidence Analytics Center of Excellence at Boehringer Ingelheim, emphasized the significance of this initiative. ‘Our investment in real-world data underscores Boehringer Ingelheim’s commitment to using cutting-edge technologies to advance medical research. By expanding this approach across more trials and commercial launches, we are positioned to drive more personalized and cost-effective treatments, ultimately transforming patient care,’ said Petraro.” Full
Dartmouth E-STaR Center Welcomes Second Cohort of Scientists
(5/2, The Dartmouth Learning Health System Embedded Scientist Training and Research Center) “The Dartmouth Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Center is proud to announce the selection of its second cohort of research scientists. This group was chosen from a competitive pool of early and mid-career researchers interested in advancing patient-centered outcomes research (PCOR) and comparative effectiveness research (CER).” Full
Journals
Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Dementia
Chen-Wen Fang, et al.
April 25, 2025, Thrombosis Research
Comparative Effectiveness of Monotherapy Vs. Combination Therapy for Postoperative Central Nervous System Infections in Neurosurgical Patients: A Retrospective Cohort Study
Muyun Li, et al.
May 2, 2025, BMC Infectious Diseases
Midurethral Sling vs OnabotulinumtoxinA in Females With Urinary Incontinence: The MUSA Randomized Clinical Trial
Heidi S. Harvie, MD, MBA, MSCE; Shawn A. Menefee, MD; Holly E. Richter, PhD, MD; et al
May 5, 2025, JAMA