Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: Methodology and external validation

Background: Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. Methods and results: We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-corners trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end poi Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n = 2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. Conclusions: A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. (c) 2012 Elsevier Inc. All rights reserved.