TY - JOUR
T1 - The FDA review on data quality and conduct in vorapaxar trials
T2 - Much better than in PLATO, but still not perfect
AU - Serebruany, Victor L.
AU - Choi, Sun Young
AU - Kim, Moo Hyun
PY - 2016/2/15
Y1 - 2016/2/15
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Data censoring
KW - Ticagrelor
KW - Trial conduct
KW - Vorapaxar
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U2 - 10.1016/j.ijcard.2015.12.001
DO - 10.1016/j.ijcard.2015.12.001
M3 - Article
C2 - 26709134
AN - SCOPUS:84955479392
SN - 0167-5273
VL - 205
SP - 13
EP - 16
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -