Ontario Protocol Assessment Level: Clinical Trial Complexity Rating Tool for Workload Planning in Oncology Clinical Trials

摘要

Abstract The Ontario Protocol Assessment Level (OPAL) protocol complexity rating scale provides a method of quantifying clinical trial activity on the basis of study protocol complexity and the resulting increase in workload. With consistent application of OPAL, sites can manage staffing objectively. Purpose: The Ontario Institute for Cancer Research supported the creation of a working group with the objective of developing a standard rating scale to evaluate clinical trial complexity and applying the scale to facilitate workload measurement for Ontario cancer research sites. Methods: The lack of a mechanism to measure the workload involved in a clinical trials protocol was identified and confirmed by a literature review. To collect information on how Ontario sites were assessing workload, a survey was distributed and evaluated. As a result, the working group developed the Ontario Protocol Assessment Level (OPAL), a protocol complexity rating scale designed to capture the workload involved in a clinical trial. After a training workshop on the application, OPAL was evaluated by 17 Ontario cancer centers to demonstrate its reliability and consistency during a 3-month pilot study. Results: Twenty-seven protocols were reviewed by multiple sites, and the majority of the sites reported OPAL score differences between 0 and 1.5. Conclusion: OPAL provides clinical trials departments with an objective method of quantifying clinical trials activity on the basis of study protocol complexity. With consistent application of OPAL, sites can manage staffing objectively. The working group is continuing to monitor the application of OPAL in Ontario.