Tutorial Reduces Protocol Deviations in Multicenter ACTG Trials with Pharmacology Endpoints

Abstract

Purpose: The AIDS Clinical Trials Group (ACTG) pharmacology quality assurance program requires clinical research staff to demonstrate minimum competencies in clinical pharmacology research. To achieve this goal, a tutorial was designed to improve the accuracy and completeness of data collected in ACTG pharmacology protocols. Method: Clinical research staff at AIDS Clinical Trials Units (ACTUs) access the tutorial through the network’s Website. The tutorial presents pharmacokinetic study concepts by contrasting poor with perfect study conduct to illustrate the influence of data quality on conclusions. Case report forms and laboratory data were audited retrospectively to examine the pre- and posttutorial incidence of targeted errors. Results: During a 2-year period, 236 study nurses at 64 main and subunit ACTUs completed the tutorial. The percentage of visits with dosing and/or sampling errors dropped from 13% to 4%. The percentage of samples with errors decreased from 6% to 3%. Sample-time errors (blood drawn outside of the 15-minute target time) decreased slightly, from 2.9% to 2.4%, but the discrepancies found in the recording of sample times decreased from 3% to <1%. Conclusion: The ACTG clinical pharmacology tutorial program improved accuracy of both protocol conduct and data collection for pharmacology objectives.

Keywords:

• data accuracy
• quality assurance
• tutorial