Thierry Fumeaux: From Efficacy to Effectiveness – The Value of Real-World Evidence
Thierry Fumeaux, Cantonal Physician – Vaud at Directorate General of Health, Vaud – DSAS, shared a post on LinkedIn about a recent article by Yu Yang et al., published in Annals of Internal Medicine, adding:
“RCTs tell us whether a drug can work under controlled conditions. Real-world data tell us whether this added value actually translates into better outcomes once the drug is widely used.
This study is a good example: in patients with atrial fibrillation and mitral stenosis, DOACs were associated with a higher 1-year risk of ischemic stroke than warfarin, despite no significant difference in bleeding or mortality.
Interestingly, they were also associated with a lower risk of myocardial infarction, illustrating how real-world effectiveness may differ across clinically relevant outcomes.
Market access should therefore not be the end of evaluation. Systematic post-market real-world evidence is essential to confirm — or challenge — the value suggested by clinical trials.
From efficacy to effectiveness: that is where the real value of innovation is ultimately measured.”
Title: Real-World Effectiveness and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis: A Target Trial Emulation
Authors: Yu Yang, Chin-Yao Shen, Michael Chun-Yuan Cheng, Wei Kang, Philip C.M. Au, Vincent K.C. Yan, Huei-Kai Huang, Chun Ka Wong, Kai Hang Yiu, Hung-Fat Tse, Ching-Lung Cheung, Timothy H. Rainer, Bryan P. Yan, David C.W. Siu, Ian Chi Kei Wong, Edward Chia-Cheng Lai, Esther W.Y. Chan
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