High Percentage of Lost To Follow-Up


High Percentage of Lost to Follow-Up
Type of indicator Risk
Risk Category Subject Population
Golden KRI YES
Therapeutic Area General
IF Risk-Event A higher than expected number of subjects are lost to follow-up
DUE TO Risk Causes Various reasons
THEN Risk Impact MAY RESULT Non-acceptance of the investigational product as a treatment of choice by health authorities
Risk Indicator High Percentage of Subjects Lost to Follow-Up
Metric Percent of Subjects Lost to Follow-Up
Unit %
What level should be measured Study, Country, Site
Comments Only subjects who have passed screening and are enrolled are included in the calculation.
Purpose Subjects lost to follow-up represent a subset of all dropouts. The proportion of dropouts due to loss to follow-up is a critical outcome measure in clinical studies, as regulators are concerned that such dropouts may result from poor outcomes related to the investigational product.
Description This KRI monitors the risk of a high percentage of subjects lost to follow-up. It triggers an alert if the percentage is higher than expected.
Formula (Number of Dropouts Due to Lost to Follow-Up) / (Number of Randomized Subjects) × 100. Use values from the same date.
Suggested Thresholds - High 5%
Suggested Thresholds - Medium 3%
Associated Metric 1 Number of Randomized Subjects
Associated Metric 2 Number of Dropouts (Lost to Follow-Up)
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