Evaluating Accuracy of The UKCRF Study Intensity Tool

Evaluating Accuracy of The UKCRF Study Intensity Tool

with STRATIFY

A Pilot Project

by

Linda Tomson Siddhi Srivastava

Contents

1. Objective 2. Materials & Methods 3. Results 4. Discussion 5. Conclusion

Objective

To evaluate the accuracy of the UKCRF Study Intensity Tool to calculate study intensity, predict workforce requirements, and estimate the cost associated with the delivery of clinical trials.

Materials & Methods

• UKCRF Study Intensity Tool
• STRATIFY Research Protocol
• STRATIFY Schedule of Events Cost Attribution Tool (SoECAT)

Results

1. Staff Whole Time Equivalent

Study Intensity Tool

STRATIFY

Figure 1: WTE of different members of staff for duration of the study

Results

2. Costs to deliver study

Figure 2: Total costs for duration of the study

Results

• No significant differences between UKCRF SIT calculations and STRATIFY delivery model.
• It appears that SOECAT is paying more tha SIT calculation, but SOECAT includes Pharmacy costs which were not included in SIT. Calculations predict STRATIFY would be paying £744 less.
• According to our initial findings, the UKCRF tool is accurate, taking into account any human errors in data entry to the tool.

Discussion

• While the Study Intensity Tool (SIT) and SOECAT initially appear to reflect study WTE appropriately, real-world delivery involves significant unaccounted variables

• Funding gaps and unaccounted costs: Coordinator/admin time, setup activities, and indirect workload are not fully captured, resulting in an overall study deficit despite apparent adequate funding.

• Questions remain around whether the UKCRF SIT accurately estimates staff workload, costs, and other delivery requirements for studies.

Conclusion

- The study was rated medium intensity score 4 with WTE of 0.63 of nurse time. Our site is broadly appropriately funded for this study type based on current UKCRF rates. - Promising results shown by our assessment, that the UKCRF tool seems accurate. However, further study is required to confirm its accuracy.

Reassess our findings once STRATIFY has ended, a before/after comparison

Ensure admin & coordinator costs are accounted for

Compare accuracy by calculating study intensity across other type of study protocols

Use the SIT to calculate whether the demand of our current portfolio matches the staffing

Thank you!