High Percentage of DropOuts


High Percentage of Dropouts
Type of indicator Risk
Risk Category Subject Population
Golden KRI YES
Therapeutic Area General
IF Risk-Event Too many subjects drop out during the study
DUE TO Risk Causes Various reasons, e.g., illness, change of mind, or travel issues
THEN Risk Impact MAY RESULT Concerns about the validity and reliability of study results
Risk Indicator High Percentage of Dropouts
Metric Percent of Enrolled Subjects Who Have Dropped Out
Unit %
What level should be measured Study, Country, Site
Comments Only subjects who have passed screening and are enrolled are included in the assessment.
Purpose A proportion of trial subjects is expected to drop out of the trial for various reasons. Assumptions on that proportion are made during study design. If the actual proportion is much higher than expected, it raises two concerns: insufficient data to draw valid conclusions, and potential safety or tolerability issues with the investigational product. Monitoring dropout levels is therefore critical.
Description This KRI monitors the risk of a high level of subject dropouts (all reasons). It triggers an alert if the percentage is higher than expected.
Formula (Number of Dropouts) / (Number of Randomized Subjects) × 100. Use values from the same date.
Suggested Thresholds - High 20%
Suggested Thresholds - Medium 15%
Associated Metric 1 Number of Randomized Subjects
Associated Metric 2 Number of Dropouts (All Reasons)
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