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 |