Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy?-Reference-Cited by-同舟云学术

Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy?

Published:2023-03-02 Issue: Volume: Page:e073100
ISSN:1756-1833
Container-title:BMJ
language:en
Short-container-title:BMJ

Author:

Wieseler Beate,Neyt Mattias,Kaiser Thomas,Hulstaert Frank,Windeler Jürgen

Publisher

BMJ

Subject

General Engineering

Reference41 articles.

1. Generating comparative evidence on new drugs and devices before approval

2. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review

3. New drugs: where did we go wrong and what can we do better?

4. Hulstaert F, Pouppez C, Primus-de Jong C, Harkin K, Neyt M. Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions; synthesis. https://kce.fgov.be/sites/default/files/atoms/files/KCE_347C_Evidence_gaps_Europe_Synthesis_V2.pdf.

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

Cited by 13 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Improving the transparency and reliability of observational studies through registration;BMJ;2024-01-09

2. R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 14;Journal of Comparative Effectiveness Research;2024-01

3. Very‐high frequency plasmapheresis and donor health–absence of evidence is not equal to evidence of absence;Transfusion;2023-11-19

4. Umgang mit best-verfügbarer Evidenz in der Nutzenbewertung von Arzneimitteln: Eine Analyse von Verfahren ohne Vorliegen einer randomisiert-kontrollierten Studie;Gesundheitsökonomie & Qualitätsmanagement;2023-10-12

5. What is the role of randomised trials in implementation science?;Trials;2023-08-16