Discrepancies in the primary PLATO trial publication and the FDA reviews.
The results of major indication seeking Phase 3 clinical trials are reported at international meetings, and simultaneously published In top medical journals. However, the data presented during such dual release do not disclose all the trial findings, suffer from overoptimistic interpretations heavily favoring the study sponsor. Ironically, after the New Drug Application is submitted for regulatory approval, and when the FDA secondary reviews become available for public, the benefit/risk assessment of a new drug is usually considered much less impressive. However, the community may ignore pivotal unreported findings later outlined in the government documents taking for granted the facts presented in the primary publication. The discrepancies between initial publication and the FDA files are not only confusing to the readership, but hold additional risks for patients. Indeed, if physicians are impressed with the initial interpretation of the trial, and do not have broad access to the FDA verified facts, chances are new agents will be prescribed based on exaggerated benefit and less safety concerns. The current pattern also hurts the reputation of the journal publishers, editors and reviewers challenging their trust and credibility. We here outline the disparity between the primary PLATO trial publication in the New England Journal of Medicine against the FDA verified numbers, and discuss how to avoid such mismatches in the future.
HeartDrug™ Research Laboratories, Johns Hopkins University, Osler Medical Building, 7600 Osler Drive, Suite 307, Towson, MD 21204, United States. Electronic address: heartdrug@aol.com.
Victor L
VL
Serebruany
D054058:Acute Coronary Syndrome / Q000517:prevention & control*; D000241:Adenosine / Q000031:analogs & derivatives / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D000077144:Clopidogrel; D003226:Congresses as Topic; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D000077486:Ticagrelor; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
D058921:Purinergic P2Y Receptor Antagonists; D000077144:Clopidogrel; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine
Clinical trial; FDA; Outcomes; Publication; Ticagrelor