Underrecruitment

Underrecruitment Table

Underrecruitment

Type of indicator Performance
Risk Category Subject Population
Golden KRI Yes
Therapeutic Area General
IF Risk-Event Enrollment is significantly less than planned
DUE TO Risk Causes Difficulties in finding patients that meet the inclusion/exclusion criteria
THEN Risk Impact MAY RESULT A low study power which is unable to determine efficacy and/or safety or a delay in the study and increased cost through protocol amendment and/or additional site start-up.
Risk Indicator Under enrollment
Metric Percent of subjects enrolled versus planned
Unit %
What level should be measured Study, Country, Site
Purpose To detect whether enrollment is to plan and indicate whether it is likely the plan for full enrollment, and therefore study timelines, will be met.
Description This KRI monitors the enrollment rate. It alarms if it is significantly lower than expected.
KEITH QUESTION: Why not also alarm if is significantly higher than expected? i.e. a KRI with an upper and lower threshold.
Formula (Number of Subjects Enrolled)/(Planned Number of Subjects Enrolled)x100. Use values from the same date.
Suggested Thresholds - High <80 %
Suggested Thresholds - Medium <90 %
Associated Metric 1 Number of Subjects Enrolled
Associated Metric 2 Planned Number of Subjects Enrolled
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