title: International central adjudication committee in the PLATO trial: independent body of experts or friendly family picnic?
abstract: The International Central Adjudication Committee (ICAC) is responsible for blinded independent assessment of complex clinical events in randomized trials. In this study, we analyze the constituence and impact of the ICAC in the PLATO trial. The PLATO ICAC was entirely governed by two academic institutions, Duke Clinical Research Institute (DCRI) and Uppsala Clinical Research Center (UCRC). Both co-chairman, all coordinators and half of the adjudicators in the PLATO ICAC belonged to either DCRI or UCRC. Among the other adjudicators representing USA, Canada and Australia, majority had DCRI ties, including at least five former Duke cardiology fellows. Furthermore, both co-chairmen are listed as adjudicators, representing obvious conflict. In the PLATO trial, the sponsor representatives were involved in selecting the ICAC members. Finally, 21 out of the 50 adjudicators represented Sweden, the homeland of the PLATO sponsor and primary investigator. Heavy selection bias in the ICAC constituence, lack of independence and potential control of the ICAC by the study sponsor may influence PLATO outcomes, and should be avoided in the future.
authors.affiliation: HeartDrug™ Research Laboratories, Johns Hopkins University, Osler Medical Building, 7600 Osler Drive, Suite 307, Towson, 21204, Maryland.
authors.forename: Victor L
authors.initials: VL
authors.lastname: Serebruany
authors.forename: Seth D
authors.initials: SD
authors.lastname: Fortmann
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000241:Adenosine / Q000031:analogs & derivatives / Q000627:therapeutic use; D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000592:standards; D000077144:Clopidogrel; D016265:Conflict of Interest; D006801:Humans; D010380:Peer Review / Q000331:legislation & jurisprudence / Q000592:standards; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D015983:Selection Bias; D000077486:Ticagrelor; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine
keywords: clinical trials; event adjudication; myocardial infarction; ticagrelor