High Percentage of DropOuts

High Percentage of DropOuts (kri)
Type of indicator Risk
Risk Category subject population
Golden KRI YES
Therapeutic Area General
IF Risk-Event many Subjects DropOut during the Study
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT non-acceptance of the Study results by health authorities
Risk Indicator High Percentage of DropOuts
Metric Percent of DropOut cases
Unit %
What level should be measured Study,Country,Site
Comments Screen failures must not been taken into account
Purpose A proportion of trial participants are expected to DropOut of the trial for various reasons. Assumptions on that proportion are made as part of the design of the study. If the actual proportion is much higher than expected this raises two concerns. First that there may not be enough data to draw a valid conclusion from the trial and second that DropOuts might be caused by the investigational product. Monitoring drop out levels is therefore important.
Description This KRI monitors the risk of a high level of participant DropOuts (due to whatever reason) at the site or for the study. It alarms if the percentage of DropOuts out of those who have enrolled is too high.
Formula Divide a value of Number of Dropouts by a value of Number of Enrolled Subjects for the same date and multiply by 100%.
Suggested Thresholds - High >20%
Suggested Thresholds - Medium >15%
Associated Metric 1 Number of Dropouts (all reasons)
Associated Metric 2 Number of enrolled Subjects
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