CER Daily Newsfeed

FDA Draft Guidance Clarifies Use of Bayesian Methods in Clinical Trials

(1/27, Katie McCool, The Evidence Base) reports “...Zhaohui Su, Vice President of Biostatistics at Ontada, described the draft as: ‘A significant advancement in the integration of real-world evidence within clinical trials,’ highlighting its support for external and non-concurrent controls when data sources are transparently justified. He added that Bayesian augmented-control designs allow sponsors to borrow from real-world sources while ‘automatically down-weighting non-exchangeable information,’ which he described as particularly important ‘in the context of rare diseases and small populations.’” Full

Harnessing RWE for Post-Pandemic Healthcare: Accelerating Drug Development with Real-World Data

(1/28, Christopher McSpiritt, MedCity News) comments “...For the best chance at successful outcomes using RWE, pharma companies should ‘start with the end in mind.’ This means designing studies with the assumption that RWE will indeed be included in the submission, and baking that into the statistical analysis plan from the get-go. It’s also crucial to inventory and prepare for the data sources required to support this — and start building the right tech stack early.” Full

The Importance of Real-World Evidence in Transforming Healthcare Decision-Making

(1/28, Clinical Trials Arena) comments “...RWE allows payers to compare the effectiveness of different clinical practices and treatment pathways in real-world care by linking treatment choices to downstream utilization, readmissions, chronic disease management performance, and patient experience. It also helps reduce care variability by highlighting what works consistently in practice and supporting approaches that direct higher-intensity interventions to patients that need them most.” Full