The FDA review on data quality and conduct in vorapaxar trials: Much better than in PLATO, but still not perfect. (15th February 2016)

• Record Type: Journal Article
• Authors: Serebruany, Victor L.; Choi, Sun Young; Kim, Moo Hyun
• Is Part Of: International journal of cardiology. Volume 205(2016)
• Page Start: 13
• Page End: 16
• Publication Date: 2016-02-15
• Subjects: Vorapaxar -- Ticagrelor -- Trial conduct -- Data censoring -- Clinical trials; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2015.12.001
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background/aims: Vorapaxar, a novel antiplatelet thrombin PAR-1 inhibitor, has been evaluated in TRA2P and TRACER trials. The drug is currently approved for post-myocardial infarction and peripheral artery disease indications with concomitant use of clopidogrel and/or aspirin. The FDA ruled that the overall vorapaxar data quality was acceptable, but conducted the sensitivity analyses for potential censoring. This was unusual, intriguing, and directly related to the challenged quality of ticagrelor dataset in PLATO in the previous New Drug Application for an oral antiplatelet agent submitted to the same Agency. Methods: Hence, we compared the FDA-confirmed evidence of conduct and data quality in vorapaxar (TRA2P, and TRACER) with those of ticagrelor (PLATO) trials. Results: The FDA provides a detailed report on information censoring, and follow-up completeness for 3 trials. TRA2P and TRACER used independent CRO for site monitoring, exhibit no heterogeneity in trial results dependent on geography, and consistent adjudication results with much less censoring than in PLATO. Conclusion: The data quality and trial conduct in vorapaxar trials were better than testing ticagrelor in PLATO, however, there is still some room for improvement especially with regard to follow-up completeness, and less information censoring.