Enrollment metric is one of the most important metric to be followed by the sites. This enrollment is the promise made by the site to enroll patients for the study of the sponsor according to the research protocols.
Enrollment metrics are critical:
Enrollment is the most important factor of the study trials as they are necessary to get to the end of the trials. In case of off enrolment metrics, there can be huge changes as making the trials more expensive, longer timelines and sponsors have to open up additional sites which cost a lot of money. These things will make the enrollment procedure as twice longer than assumptions and shows the critical sides of the enrollment metric.
Enrollment metric can be tracked by percent attainment of sponsor enrollment goal as a leading indicator. Leading indicator is the metric that is when you get the number, you can still do something about it. Lagging indicator is when you get a number, you can no longer do anything about it.
Tracking enrollment as a rate in real time when sites are below the goal or they want to achieve enrollment goal, they can add to their marketing dollars, can contact additional physician offices, pulling additional lists out of EMR and several others attempts to reach to their target goal in order to well serve the sponsor with enrollment.
Sponsor enrollment goal:
If the sites promise to put ten patients in the study trial and research trials are going to last for ten months then it should be putting every patient for at least one month. Site is going above the goal when the numbers of patients go above the number of patients required per month and they are targeting on the rates to achieve sponsor enrollment goal.
Site is unable to achieve sponsor enrollment goal when it could not find enough required number of patients for the study trials.
- Lagging indicator that we also track is when the trial close to enrollment and they know the number but can’t do anything about it as it’s the final score. This is also tracked at the end of the day according to the percent attainment of sponsor enrollment goal but not as rate, as an absolute value.
Sponsors do check:
Sponsors also heck on sites but they do not track percent attainment of sponsor enrollment goal and the promises at beginning of the trials. Sponsor tract at the end of the trial that how site perform against their peers. This is to identify the difference in individual research protocols.
- Sites much check on their scorecards in order to serve well their sponsor and to achieve their desired goals.