High Percentage of Treatment Interruption

High Percentage of Treatment Interruption Table
Type of indicator Risk
Risk category Investigational Medicinal Product (IMP)
Golden KRI NO
Therapeutic area General
IF risk event Treatment with the investigational product is interrupted for one or more participants
DUE TO risk causes Occurrence of serious adverse events, tolerability issues, or logistical problems with drug supply
THEN risk impact may result Reduced number of per-protocol participants and potential inability to adequately assess investigational product efficacy
Risk indicator High percentage of treatment interruption
Metric Percentage of enrolled subjects with treatment interruptions
Unit %
What level should be measured Study, country, site, subject
Purpose Ensure continuous subject treatment with the investigational product by identifying high rates of treatment interruptions, supporting timely corrective actions, and safeguarding study integrity.
Description This KRI monitors the proportion of subjects whose treatment was interrupted. Elevated rates may indicate safety issues, tolerability problems, or operational challenges requiring further investigation.
Formula (Number of randomized subjects with treatment interruptions ÷ Total number of randomized subjects) × 100%
Suggested thresholds - high 5%
Suggested thresholds - medium 3%
Associated metric 1 Number of randomized subjects
Associated metric 2 Number of randomized subjects with treatment interruptions
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