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

Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

(2020) Jim Slattery et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Randomised controlled trials versus real world evidence: neither magic nor myth

(2020) Hans‐Georg Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Randomized, observational, interventional, and real‐world—What's in a name?

(2020) John Concato et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Evaluating the Use of Nonrandomized Real World Data Analyses for Regulatory Decision Making

(2019) Jessica M. Franklin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

(2019) Alison Cave et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Patient Registries: An Underused Resource for Medicines Evaluation

(2019) Patricia McGettigan et al.   DRUG SAFETY

Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017

(2019) Jeremy Philip Brown et al.   BMJ Open

The use of real-world data in cancer drug development

(2018) E. Skovlund et al.   EUROPEAN JOURNAL OF CANCER

Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators

(2018) Alexandra Pacurariu et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

(2018) Caridad Pontes et al.   Orphanet Journal of Rare Diseases

Registries supporting new drug applications

(2017) Carla J. Jonker et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013

(2017) Jacoline C. Bouvy et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

(2016) Anthony J Hatswell et al.   BMJ Open