IRST WL: a tool to measure the workload of clinical research coordinators in oncology

Abstract

Background: Cancer clinical trials (CT) have become more complex and require dedicated personnel (Clinical Research Coordinators [CRC]) involved in activities including regulatory and administrative aspects and protocol- and patient-related procedures. Few experiences on how to measure the workload (WL) of a CT have been published. We measured the specific WL of CRCs using a simple, objective tool developed at our institute. Methods: TheWL measurement tool considers 3 aspects of trial complexity: protocol management-related WL and patient (pt) management-relatedWL, subdivided into pt treatment management-relatedWL and pt follow-up management-relatedWL. A partial score is calculated for each section based on the specific score for: a) study promoter (profit, no profit); b) frequency of monitoring site visits; c) disease setting (advanced, adjuvant, neoadjuvant); d) number of centralized procedures; e) frequency of hospital visits to receive treatment; f ) type of follow-up. The WL score pertaining to the study protocol (a-b) is trial-specific and not related to pt numbers. Scores for the treatment and follow-up sections are multiplied by the number of pts still undergoing treatment (c-d-e) and the number undergoing follow-up (f ). The total WL for each trial is the sum of protocol-related partial scores and pt-related partial scores. IRST WLs were measured each month by 19 full-time CRCs in 7 sites of the Romagna Oncology Network to evaluate the reproducibility (when the study was active in two or more network sites) and accuracy of the measurement tool. Results: From 1.04.15 to 31.03.15, 215 CRC WLs were calculated. Each CRC was involved in a median of 22 trials (range 5-52). More than 50% of studies were active in two or more Network sites and score reproducibility was very high (> 90%), with little difference in the number of centralized procedures and frequency of site monitoring visits. Variations in total WL scores among CRCs (from 270 to 950) and differences over time (up to 15% from month to month) were observed, reflecting the subjective perceived workload, regardless of the involved number of ongoing trials and recruited pts. A monthly score of between 450 and 600 was hypothesized as an appropriate WL value for a full-time CRC. Conclusions: The IRST WL measurement tool could be a valuable aid to evaluating clinical trial complexity, estimating appropriate workloads for full-time CRCs, and planning personnel resource requirements.