Clinical Trial Performance Metrics 101
Clinical trial performance metrics are among the most powerful tools for assessing progress, decision making, and measuring the strength of evidence used in clinical trials. These metrics are vital for both sponsors and regulatory authorities to make informed decisions about continuing a clinical trial, modifying the trial protocol, selecting the sample size for statistical power, or terminating a study early. These metrics clarify a trial’s performance expectations regarding patient recruitment and retention, which drives both cost-effectiveness and efficiency. This is called the "critical path" in the drug development industry (i.e., when a clinical trial starts and ends, how long it takes). As the number of clinical trials increase year after year, planning and monitoring is more important than ever. What Are Clinical Trial Metrics?Clinical trial performance metrics are the numbers used to measure the performance of a clinical research team. This includes site patient accrual, site staff compliance with study procedures, site accuracy in data entry, and site retention rates. Sites are measured based on these metrics so that researchers can determine whether they are being effective.The Importance of Measuring Site PerformanceClinical research organizations (CROs) rely on clinical trial data to make decisions about effective sites. Sites that do not meet acceptable performance levels may be dropped from studies or added to the list of sites that are excluded from ongoing study selection processes. Before being considered for future work, a site must prove itself to be effective at managing the clinical trial.How to Measure Site PerformanceSite performance is generally measured by researchers on three core metrics: 1) patient enrollment rate, 2) data accuracy, and 3) retention/attrition rate. All three are critical for developing an accurate picture of whether your clinic is meeting its recruitment goals.1. Patient Enrollment RateIn the fast-paced world of clinical trials, speed is essential. The faster a site…