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 products as the treatment of choice by health authorities
Risk Indicator
High percentage of participants lost to follow-up
Metric
Percent of lost to follow-up
Unit
%
What level should be measured
Study, Country, Site
Comments
Only participants who have passed screening and are enrolled are included in the calculation.
Purpose
Participants lost to follow-up are a subset of all drop outs. The proportion of drop outs during follow-up is critical in outcome studies as regulators are concerned dropouts may be 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. It alarms if the percentage is higher than expected.
Formula
(Number of Dropouts Due to Lost To Follow-Up)/(Number of Randomized Subjects)x100. 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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