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Platelet Aggregation Quality Control in a Multicenter Phase 2 Clinical Trial

Title
Platelet Aggregation Quality Control in a Multicenter Phase 2 Clinical Trial

Abstract
Platelet aggregation assays provide vital information on pharmacodynamics and population variability in clinical trials of antiplatelet agents. However, nonexpert operators in multiple trial sites may generate artifactual results, reducing data quality. This study aimed to determine whether platelet aggregation assays performed in a phase 2 trial of a novel antiplatelet agent were of sufficient quality to assess the drug’s effectiveness. A specialist contract research organization with expertise in platelet function analysis developed procedures for training and providing feedback to operators, and a data monitoring and review process, classifying data as usable or artifactual. Usable platelet aggregation data was obtained from over 90% of assayed time points. Site choice, training, and ongoing support contributed to the generation of high-quality aggregation data, with the assay success rate improving during the trial. Independent data review objectively identified artifactual platelet aggregation assay results, allowing better use of study data to determine drug effects and population differences.