title: The FDA review on data quality and conduct in vorapaxar trials: Much better than in PLATO, but still not perfect.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. Electronic address: vserebr1@jhmi.edu.
authors.forename: Victor L
authors.initials: VL
authors.lastname: Serebruany
authors.affiliation: Clinical Trial Center, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Republic of Korea.
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Choi
authors.affiliation: Clinical Trial Center, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Republic of Korea.
authors.forename: Moo Hyun
authors.initials: MH
authors.lastname: Kim
mesh_terms: D000241:Adenosine / Q000031:analogs & derivatives / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000453:epidemiology; D000068598:Data Accuracy; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic / Q000592:standards*; D011725:Pyridines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D000077486:Ticagrelor; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*; D010975:Platelet Aggregation Inhibitors
chemical_list: D007783:Lactones; D011725:Pyridines; D000077486:Ticagrelor; D000241:Adenosine; C530299:vorapaxar; D010975:Platelet Aggregation Inhibitors
keywords: Clinical trials; Data censoring; Ticagrelor; Trial conduct; Vorapaxar