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

  • James McRedmondEmail author
Clinical Trials

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 suff-cient 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 identifed artifactual platelet aggregation assay results, allowing better use of study data to determine drug effects and population differences.

Keywords

Platelet aggregation assay Quality control Data review Antiplatelet drugs Multicenter trial 

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Copyright information

© Drug Information Association, Inc 2011

Authors and Affiliations

  1. 1.Java Clinical ResearchFitzwilliam Business CentreDublin 2Ireland

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