Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth

Author:

Eichler Hans‐Georg12,Pignatti Francesco1,Schwarzer‐Daum Brigitte23,Hidalgo‐Simon Ana1,Eichler Irmgard1,Arlett Peter14,Humphreys Anthony1,Vamvakas Spiros1,Brun Nikolai5,Rasi Guido16

Affiliation:

1. European Medicines Agency (EMA) Amsterdam The Netherlands

2. Medical University of Vienna Vienna Austria

3. EMA’s Committee for Orphan Medical Products (COMP) Amsterdam The Netherlands

4. London School of Hygiene and Tropical Medicine London UK

5. Danish Medicines Agency Copenhagen Denmark

6. University Tor Vergata Rome Italy

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference28 articles.

1. The Magic of Randomization versus the Myth of Real-World Evidence

2. Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers

3. Alliance for Regenerative Medicines website: ARM Annual Report & Sector Year in Review (2019).

4. Statement from FDA Commissioner Scott Gottlieb M.D. and Peter Marks M.D. Ph.D. Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies (2019).

5. Pharmacogenetic Study of Statin Therapy and Cholesterol Reduction

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