Prospective evaluation of the adapted Ontario Protocol Assessment Level score for predicting clinical research...

Area of Science:

• Clinical Research Operations
• Health Services Research

Background:

• Increasing clinical trial protocol complexity elevates research coordinator workload, leading to staffing shortages and operational inefficiencies.
• These challenges disproportionately affect under-resourced and minority-serving institutions, potentially limiting trial implementation.
• Accurate estimation of coordinator effort is crucial for effective clinical trial planning, resource allocation, and successful execution.

Purpose of the Study:

• To evaluate the predictive accuracy of an adapted Ontario Protocol Assessment Level (OPAL) score for research coordinator workload.
• To enhance operational planning and resource management in clinical research settings.

Main Methods:

• A 12-month prospective observational study was conducted at a Historically Black College and University medical school.
• Seven research coordinators meticulously recorded hours spent on seven actively enrolling interventional trials.
• Workload estimations using an adapted OPAL reference table were compared against actual recorded hours via descriptive statistics and paired t-tests, applying standardized workday equivalencies.

Main Results:

• No statistically significant difference was observed between estimated and actual coordinator hours (average difference: 24.1 hours, p=0.761).
• The mean absolute error in workload estimation was 167.0 hours, approximately equivalent to one full-time work month.

Conclusions:

• The adapted OPAL score offers a practical method for estimating research coordinator workload and matching staffing levels to protocol demands, even in resource-limited environments.
• Further multi-site validation is necessary to confirm the generalizability of the adapted OPAL score and support its adoption in clinical trial feasibility planning.