High Percentage of Lost To Follow-Up

High Percentage of Lost To Follow-Up (kri)
Type of indicator Risk
Risk Category subject population
Golden KRI YES
Therapeutic Area General
IF Risk-Event a high number of Subjects are lost to follow-up
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT non-acceptance of the investigational products as the treatment of choice by health authorities
Risk Indicator High Percentage of Lost To Follow-Up
Metric Percent of lost to follow-up
Unit %
What level should be measured Study,Country,Site
Comments Screen failures must not been taken into account
Purpose Dropouts due to loss to follow-up are a subset of all dropouts from the trial. The proportion of these dropouts is critical in outcome studies as regulators are concerned with a high dropout rate that the dropouts may be disproprtionately due to poor outcomes caused by the investigational product.
Description This KRI monitors the risk of a high level of participant drop-outs due to loss to follow-up at the site or for the study. It alarms if the percentage of drop-outs out of those who have enrolled is too high.
Formula Divide a value of Number of Dropouts Due to Lost To Follow-Up by a value of Number of Enrolled Subjects for the same date and multiply by 100%.
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of dropouts due to lost to follow-up
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