Adjudication of a primary trial outcome: Results of a calibration exercise and protocol for a large international trial

Author:

Cook DeborahORCID,Deane Adam,Dionne Joanna C.,Lauzier François,Marshall John C.,Arabi Yaseen M.,Wilcox M. Elizabeth,Ostermann MarliesORCID,Al-Fares AbdulrahmanORCID,Heels-Ansdell Diane,Zytaruk Nicole,Thabane Lehana,Finfer Simon

Publisher

Elsevier BV

Reference15 articles.

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2. European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure.https://www.ema.europa.eu/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-chronic-heart-failure-revision-2_en.pdf. Accessed October 11, 2023..

3. Clinical event adjudication in cardiovascular device trials: a Food and Drug Administration perspective;Farb;Am. Heart J.,2017

4. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium;Mehran;Circulation,2011

5. When do we need clinical endpoint adjudication in clinical trials?;Held;Ups. J. Med. Sci.,2019

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