News from Tuesday, April 28, 2026
Articles
FDA Expects Inpatient Pay Rule To Boost Real-World Device Data
(4/27, Christian Robles, Inside Health Policy) reports “...The policy tucked into CMS’ draft 2027 inpatient pay rule comes as the Trump administration is allowing medical devices to use real-world data for certain types of medical device submissions and requiring real-world data collection for participation in the TEMPO pilot. The proposed UDI policy does not mandate the inclusion of UDIs in Medicare claims, an issue lawmakers and HHS officials have long sought to address.” Subscription Required
FDA Commissioner: ‘Smarter,’ Real-Time Clinical Trials Could Transform Drug Development
(4/28, Marty Makary, STAT) comments “...For the first time, FDA regulators will be able to see what’s happening in a clinical trial, looking at endpoints in the cloud as they occur. This is an important step toward our broader goal of moving toward continuous trials, reducing dead time in the system...By viewing safety signals and clinical endpoints in real time, FDA scientists can detect adverse reactions sooner, potentially enhancing patient safety. Conversely, when a new therapy is showing strong efficacy, we can identify that success rapidly.” Subscription Required
Video: Asembia AXS26: Jessica Lovett on the RWE That Matters Most
(4/28, Jessica Lovett, Stephen Appezzato, Pharmaceutical Commerce) “...Jessica Lovett, VP of Commercial Strategy and Innovation at Innomar Strategies, shares her perspective on where the most valuable real-world data are coming from today in support of specialty medicines. Lovett shared her insights at the conference's session ‘Unlocking Value and Access: The Power of RWE in the Product Lifecycle to Maximize Patient Benefit,’ which explored how real-world evidence can be applied across every stage of a specialty therapy's lifecycle, from early development and clinical trials through regulatory submissions and post-market evaluation, with the ultimate goal of maximizing benefit for patients.” View Video
Video: How Can Pharma Prices be Reduced for Americans Without Impacting Innovation?
(4/27, Mike Hollan, Dr. Stella Vnook, PharmExec) “...[Dr. Stella Vnook, chair and acting CEO of Kaida BioPharma:] There is a lot to be done in terms of value-based contracting. I've been in the industry for 25 years. We talked about these contracts with limited success. They're difficult to execute, but there is more that can be done.” View Video
Press Releases
PCORI Awards Funding for New Patient-Centered Healthcare Research Supporting Better-Informed Decision Making
(4/28, PCORI Press Release) “...‘Understanding the tradeoffs between different approaches to care helps patients and their caregivers navigate decisions in everyday clinical settings,’ said PCORI Executive Director Nakela L. Cook, M.D., MPH. ‘These newly funded patient-centered comparative clinical effectiveness research projects will generate evidence to help people across the United States understand their options and make better-informed choices that reflect their needs and preferences.’” Full
Researcher Wins Second Award to Support People with Cerebral Palsy
(4/27, Texas Woman’s University Press Release) “...The award supports the launch of the Cerebral Palsy – Training in Research, Assessment and Intervention Network (CP-TRAIN). CP-TRAIN will work alongside people with cerebral palsy, their families, therapists, clinicians and researchers to create foundational modules and a therapist certification pathway. This work will culminate in a prioritized agenda for comparative clinical effectiveness research.” Full
Duke & UNC Researchers to Co-Lead $12.9M Study to Improve Care for Autistic Children
(4/28, Duke Health Press Release) “...The multi-site, randomized, head-to-head clinical trial will compare the effectiveness of linaclotide to the current standard treatment, polyethylene glycol 3350 (PEG-3350, commonly known by the brand name MiraLAX®) for treating constipation in autistic children. The study team aims to recruit 320 patients from 30 sites across the nation, drawing from general pediatrics, developmental pediatrics, and pediatric gastroenterology practices at large freestanding children’s hospitals and smaller hospitals and clinics.” Full
Truveta Unveils Truveta Intelligence, Delivering Real-Time Insights from Real-World Data
(4/28, Truveta Press Release) “...Built on Truveta Data, Truveta Intelligence reflects the real-world care of more than 130 million patients across all care settings and therapeutic areas with data that is continuously refreshed and grounded in the electronic health records of Truveta’s member health systems. Each question is translated into structured analysis across this longitudinal data, returning intelligence that reflects contemporary clinical practice—not static datasets or historical snapshots. Every result is fully inspectable, enabling teams to validate findings and confidently advance to downstream evidence generation.” Full
Journals
A Real-World Study on the Comparative Effectiveness of First-Line Treatment Regimens in Advanced NSCLC Patients with PACC Mutations
Dujiang Liu, et al.
April 20, 2026, Therapeutic Advances in Medical Oncology
Annals Guide to Journal Club - Comparative Effectiveness and Safety of Apixaban, Rivaroxaban, and Warfarin in Patients With Cirrhosis and Atrial Fibrillation
Jose D Cruz-Cuevas, Christina C Wee
April 28, 2026, Annals of Internal Medicine
Beyond Numbers: Uses and Value of In-Trial Interview Data for Regulatory and Health Technology Assessment (HTA) Decision Making
Carla Dias-Barbosa, et al.
May 2026, The Patient - Patient-Centered Outcomes Research