Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

• Real-time data in cancer registries: Validation of an automated data extraction system

  2025 iScience article Health Professions Electronic Health Records Systems Open access

  5

  citations
• Multiple Perspectives on the Need for Real‐World Evidence to Inform Regulatory and Health Technology Assessment Decision‐Making: Scoping Review and Stakeholder Interviews

  2025 Pharmacoepidemiology and Drug Safety article Economics, Econometrics and Finance Health Systems, Economic Evaluations, Quality of Life Open access

  6

  citations
• Real‐World Evidence to Inform Regulatory Decision Making: A Scoping Review

  2024 Clinical Pharmacology & Therapeutics article Economics, Econometrics and Finance Pharmaceutical Economics and Policy Open access

  10

  citations
• Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency

  2023 European Heart Journal - Quality of Care and Clinical Outcomes article Economics, Econometrics and Finance Pharmaceutical Economics and Policy Open access

  5

  citations
• Regulatory agencies disregard real-world effectiveness evidence on product labels beyond what is reasonable

  2022 Journal of Clinical Epidemiology article Pharmacology, Toxicology and Pharmaceutics Pharmaceutical industry and healthcare

  0

  citations
• EULAR points to consider when analysing and reporting comparative effectiveness research using observational data in rheumatology

  2022 Annals of the Rheumatic Diseases article Mathematics Advanced Causal Inference Techniques Open access

  25

  citations
• Localized Peripheral Neuropathic Pain: Topical Treatment with Lidocaine 700 mg Medicated Plaster in Routine Clinical Practice

  2022 Pain Management article Medicine Pain Mechanisms and Treatments Open access

  9

  citations
• Analysing and reporting of observational data: a systematic review informing the EULAR points to consider when analysing and reporting comparative effectiveness research with observational data in rheumatology

  2021 RMD Open review Decision Sciences Meta-analysis and systematic reviews Open access

  8

  citations
• Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?

  2021 Clinical Pharmacology & Therapeutics article Economics, Econometrics and Finance Pharmaceutical Economics and Policy Open access

  133

  citations
• Tapentadol Prolonged Release in Patients with Chronic low back Pain: Real-World Data from the German Pain eRegistry

  2021 Pain Management article Medicine Pain Management and Opioid Use Open access

  12

  citations
• Lidocaine 700 mg Medicated Plaster for Postherpetic Neuralgia: Real-World Data from the German Pain E-Registry

  2021 Pain Management article Medicine Herpesvirus Infections and Treatments Open access

  10

  citations
• An Electronic Health Record Text Mining Tool to Collect Real‐World Drug Treatment Outcomes: A Validation Study in Patients With Metastatic Renal Cell Carcinoma

  2020 Clinical Pharmacology & Therapeutics article Health Professions Electronic Health Records Systems Open access

  48

  citations

12 results