The CTMS Report "03.02 Startup Tracking" includes calculations on Actual/Target Enrollment Rate KPI. The following paragraphs will describe how this figure is calculated.
In order to be able to calculate the Actual/Target Enrollment Rate KPI, the following data must be entered in SimpleTrials:
- First Patient In date as a Study Event in Milestones & Tasks view
- Last Patient In date as a Study Event in Milestones & Tasks view
- Target # Subjects Enrolled in Startup Tracking view for each site in the study
- Actual # Subjects Enrolled as noted in Startup Tracking view
- Ensure that either the “Sync Actuals” button is clicked prior to running the report or set the Startup Tracking Automation in STUDY > STUDY PROFILE Section 9 to automatically update the actuals on a daily basis.
With these data points, the following information can be calculated to arrive at the KPI:
- Enrollment Duration is the difference between First Patient In date and Last Patient In date
- This is used to calculate the denominator of the Target Daily Enrollment Rate
- Target Daily Enrollment Rate = Target # Subjects Enrolled / Enrollment Duration
- Actual Daily Enrollment Rate = Actual # Subjects Enrolled / (Current Date – First Patient In Date)
- Note that if the Current Date is later than the Last Patient In Date, the calculation will be equal to the Enrollment Duration as noted above.
- Actual/Target Enrollment Rate = Actual Daily Enrollment Rate / Target Daily Enrollment Rate
An example with data may be helpful. Let's assume the following milestones have been entered:
- First Patient In Date = 18 June 2020
- Last Patient In Date = 26 September 2020
- Site Target # Subjects Enrolled = 10
- Actual # Subjects Enrolled = 6
- Current Date (i.e. date report run) = 07 August 2020
Calculations:
- Enrollment Duration = 100 days
- Current Date – First Patient In Date = 50 days
- Target Daily Enrollment Rate = 10 / 100 = 0.10
- Actual Daily Enrollment Rate = 6 / 50 = 0.12
- Actual / Target Enrollment Rate KPI = 0.12 / 0.10 = 1.2
Therefore, the site will have a KPI value of 1.2 which means that it is enrolling 20% faster than its target rate based on the Study Milestones.
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