Underrecruitment
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 |