In response to perceived increases in clinical trial complexity and concomitant greater demands on staffing resources, the University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) endeavored to quantify the amount of effort required by its staff to efficiently and effectively conduct clinical trials. With the development of a homegrown Research Effort Tracking Application (RETA), the CTO was able to obtain real-time metrics related to staff time required to conduct therapeutic clinical trials. Using a Web-based tool, CTO staff record how much time they spend each day performing specific study-related and general office tasks. The information gathered was incorporated into study budget preparation to aid in budget negotiation and cost recovery. RETA not only assisted in budget development but also yielded information that significantly improved workload allocation and incremental staff justification. Before the implementation of RETA in December 2005, study budgets were based on either a best estimate of the resources required, or the dollar amount offered by a sponsor to perform the study. Allocation of workload was also a challenge, because the effort required by data management and regulatory staff to complete their study-related responsibilities was poorly understood.
The development of RETA is described in greater detail in a previous paper.1 In brief, the RETA tool provides staff with a Web-based method for tracking the amount of time spent performing study-related activities on a daily basis. Staff choose from a list of activities related to their job function (i.e., data management or regulatory) and indicate how much time they spent on that activity and for which study. This differs from a traditional time study in that RETA is used on a daily basis across all studies conducted in the UMCCC CTO, rather than having information gathered about only a handful of studies. It is a flexible tool capable of capturing changes in effort as research requirements and protocol complexity change. The usefulness of RETA has made it indispensible to UMCCC CTO operations. These data are being incorporated into the office's payroll process and are allowing managers to monitor how staff are spending their time on an ongoing basis.
This article discusses the method used to analyze the data yielded and to compare the impact of the primary study characteristics identified. The results and discussion examine what the authors learned in their 4-year analysis, and how the findings agree with or differ from conventional wisdom about the staff effort associated with the conduct of clinical trials. The authors will also describe how the CTO has incorporated these findings into the current and prospective management of studies coordinated through their office.
The authors would like to thank Janet Tarolli, RN, BSN, CCRC, and Joy Stair, MS, BSN, for serving as editors.
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