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The FDA and PLATO Investigators death lists: Call for a match.

Victor L Serebruany1, Jean-Francois Tanguay2, Thomas A Marciniak3

  • 1Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.

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Summary

Primary death cause reporting in the PLATO trial showed discrepancies between the FDA dataset and investigator data. This analysis highlights significant mismatches in causes of death, questioning data integrity.

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Area of Science:

  • Cardiovascular Research
  • Clinical Trial Data Analysis
  • Pharmacovigilance

Background:

  • The PLATO trial investigated ticagrelor versus clopidogrel.
  • Concerns were raised regarding potential bias in reporting primary death causes (PDCs) favoring ticagrelor.
  • The quality and completeness of the investigator-operated death list were questioned.

Purpose of the Study:

  • To compare the accuracy and consistency of primary death cause reporting between the FDA-issued dataset and the PLATO Investigators' dataset.
  • To identify and quantify discrepancies in specific causes of death between the two data sources.

Main Methods:

  • A comparative analysis of primary death causes for 938 deaths in the FDA dataset versus 905 deaths in the investigator dataset.
  • Matching of four vascular (sudden, post-MI, heart failure, stroke) and three non-vascular (cancer, sepsis, suicide) PDCs between the two lists.

Main Results:

  • Significant mismatches were observed in sudden deaths (161 vs 138) and post-MI deaths (373 vs 178), with higher numbers in the investigator list.
  • Fewer heart failure deaths (73 vs 109) were reported in the investigator list.
  • Stroke, cancer, and sepsis PDCs showed good agreement, but two unexplained additional clopidogrel suicide deaths were noted in the investigator list.

Conclusions:

  • The primary death cause data in the PLATO trial exhibited significant mismatches between the FDA and investigator datasets.
  • These discrepancies raise concerns about the reliability of the reported causes of death.
  • Clarification from the ticagrelor sponsor and PLATO Investigators is requested regarding the observed PDC data inconsistencies.