CER Daily Newsfeed

Podcast: How Health Data Interoperability Can Improve Patient Care

(9/25, J.B. Wogan, Mathematica: On the Evidence) comments “This episode of Mathematica’s On the Evidence podcast focuses on the potential for health data interoperability to improve people’s health and well-being. Improved data interoperability is part of a broader push in the public and private sectors to use digital technology to make greater volumes of data available faster, at lower cost, and in higher quality formats. These advances would make data easier to access, especially when needed to prevent or address urgent problems. In health care, the digital transformation in data could keep people healthier by improving the speed and quality of care patients receive.” Full

Euro Roundup: Commission Posts Guide to Validity of Studies for Joint Clinical Assessments

(9/26, Nick Paul Taylor, Regulatory Focus) reports “...‘Methodological systems that entail not only assessment, but also appraisal, cannot (or only partially) be applied in European HTA, since appraisal includes value judgment and (pre-)determines a decision on pricing and reimbursement of a health technology,’ the guidance states. Yet, valid scientific principles are still required to guide JCA development and ensure results are understandable at a national level. The guidance is intended to further that aim by defining, classifying and assessing the certainty of results of studies in an objective, reproducible and transparent way ‘leading to the statistical analysis of data considered as originating from or part of a single study (i.e., one sample of patients),’ the document states.” Full

New EU HTA Guidance OKs Single-Arm Studies, But More Work Needed On Evidence Gaps

(9/26, Francesca Bruce, Pink Sheet) reports “...New guidance from the European Commission on clinical trial validity for forthcoming joint clinical assessments has eased some concerns about the generation of evidence for rare disease treatments and advanced therapies.” Subscription Required