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References from Toward the Use of Real‐World Data for Regulatory and HTA Decision‐Making: Experiences and Recommendations from Six EU ‐Funded Projects. Local targets link to admitted publications; unresolved targets remain external evidence.
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Stakeholders' perspectives toward the use of patient registry data for decision‐making on medicines: a cross‐sectional survey
10.1007/s40264-025-01528-7 · 2025 · External reference
Key stakeholders' knowledge, opinions, and interests on real‐world evidence in the regulatory process—results of an EU ‐wide survey
10.1111/cts.70454 · 2025 · External reference
If it wasn't for us, there would be no data: stakeholders' perspectives on patient involvement in the use of health data in Ireland
10.1186/s40900-025-00761-9 · 2025 · External reference
Implementation of the European health data space: a qualitative study on expectations of health data experts from 23 countries
10.1016/j.healthpol.2025.105428 · 2025 · External reference
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The EU project Real4Reg: unlocking real‐world data with AI
10.1186/s12961-025-01287-y · 2025 · External reference
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Eliminating the AI digital divide by building local capacity
10.1371/journal.pdig.0001026 · 2025 · External reference
Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): lessons learnt from the MINERVA project in Europe
10.1002/pds.5884 · 2024 · External reference
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Advancing real‐world evidence through a federated health data network (EHDEN): descriptive study
10.2196/74119 · 2025 · External reference
GEN‐RWD sandbox: bridging the gap between hospital data privacy and external research insights with distributed analytics
10.1186/s12911-024-02549-5 · 2024 · External reference
HARmonized protocol template to enhance reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force
10.1002/pds.5507 · 2023 · External reference
Real‐world evidence to support EU regulatory decision making—results from a pilot of regulatory use cases
10.1002/cpt.3355 · 2024 · External reference
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Survival analysis for AdVerse events with VarYing follow‐up times (SAVVY): summary of findings and assessment of existing guidelines
10.1186/s13063-024-08186-7 · 2024 · External reference
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Regularized estimation in sparse high‐dimensional multivariate regression, with application to a DNA methylation study
10.1515/sagmb-2016-0073 · 2017 · External reference
FRAME: framework for real‐world evidence assessment to mitigate evidence uncertainties for efficacy/effectiveness – an evaluation of regulatory and health technology assessment decision making
10.1002/cpt.3713 · 2025 · External reference
