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Martin Scott, S. Gsteiger, O. Dohring, et al. | Navigating Priorities, Statistical Rigor, and Decision-Making on Multiplicity Questions in the Context of the EU Joint Clinical Assessment. | Statistics in Biopharmaceutical Research, 2026 | Category: JCA
Multiplicity in EU Joint Clinical Assessment
Multiplicity is emerging as a key methodological challenge within the EU Joint Clinical Assessment (JCA) framework. While regulatory settings focus on hypothesis testing and Type I error control, HTA decision-making requires a broader perspective on evidence interpretation …
Martin Scott, Scientific Director | Posted on: 04-02-2025 | Category: RWD
Utilising real-world data for EU HTA
In the evolving landscape of healthcare, real-world data (RWD) has emerged as a vital resource. But what exactly is RWD? It encompasses information about patient health, experiences, and care delivery collected outside the controlled environment of clinical trials. This data is increasingly used for marketing authorisations and health technology assessments (HTA) in the EU. However, while RCTs (randomised controlled trials) remain the gold standard for demonstrating causality, …
Jonathan Alsop PhD and Lawrence Pont MSc | Posted on: 06-23-2022 | Category: MAIC
Matching-adjusted indirect comparison via a polynomial-based non-linear optimisation method
Reimbursement authorities need the best available evidence when comparing treatments. This evidence is arguably best obtained from randomised controlled trials. However, for many valid scientific and commercial reasons, …
PD Dr. rer. nat. Hans-Peter Dürr | Posted on: 06-19-2022 | Category: Epidemiology
Corona pandemic: future considerations based on epidemiological modelling results
Since the emergence of the corona pandemic, there has been a worldwide question regarding when the pandemic would come to an end. In the meantime, such hopes are increasingly being supplanted by concerns that this infectious …
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