Effort Tracking Metrics Provide Data for Optimal Budgeting and Workload Management in Therapeutic Cancer Clinical Trials

Abstract

Clinical trials operations struggle to achieve optimal distribution of workload in a dynamic data management and regulatory environment, and to achieve adequate cost recovery for personnel costs. The University of Michigan Comprehensive Cancer Center developed and implemented an effort tracking application to quantify data management and regulatory workload to more effectively assess and allocate work while improving charge capture. Staff recorded how much time they spend each day performing specific study-related and general office tasks. Aggregated data on staff use of the application from 2006 through 2009 were analyzed to gain a better understanding of what trial characteristics require the most data management and regulatory effort. Analysis revealed 4 major determinants of staff effort: 1) study volume (actual accrual), 2) study accrual rate, 3) study enrollment status, and 4) study sponsor type. Effort tracking also confirms that trials that accrued at a faster rate used fewer resources on a per-patient basis than slow-accruing trials. In general, industry-sponsored trials required the most data management and regulatory support, outweighing other sponsor types. Although it is widely assumed that most data management efforts are expended while a trial is actively accruing, the authors learned that 25% to 30% of a data manager's effort is expended while the study is either not yet open or closed to enrollment. Through the use of a data-driven effort tracking tool, clinical research operations can more efficiently allocate workload and ensure that study budgets are negotiated to adequately cover study-related expenses.

Assessing the challenges of multi‐scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks

“…Such activities have been found to present barriers in other clinical trials management examinations , with implications for successful trial implementation and completion. Dealing with multiple IRB reviews , meeting accrual sufficiency , recruitment and retention, generally and of minority populations specifically , budgeting and cost allocation , and results dissemination have all been identified as potential barriers in the clinical trials literature and have been shown to impact successful clinical trials outcomes.…”

Creating an Effort Tracking Tool to Improve Therapeutic Cancer Clinical Trials Workload Management and Budgeting

“…Over a 4-year period, the data obtained from use of this tool have not only assisted with workload management, trial budget development, and cost recovery, but have also compelled the group to think critically about clinical trials management and enabled them to identify the most complex and time-consuming tasks that affect the bottom line. A subsequent article 6 provides an analysis of the data yielded and discusses trial characteristics and the impact of those characteristics on workload and resource allocation.…”

Patient Acuity Related to Clinical Research: Concept Clarification and Literature Review

“…Finally, one was a quality improvement study (Cusack et al, 2004a(Cusack et al, , 2000bJones et al, 2004) and two were expert opinion or commentary (Cassidy & Macfarlane, 1991;Smuck et al, 2011). In relation to psychometric assessments, eight had no reliability and validity data reported (Berridge et al, 2010;Ellis et al, 2012;Good et al, 2013;Gwede et al, 2000aGwede et al, , 2000bJames et al, 2011aJames et al, , 2011bMcCarthy, 1997;Roche et al, 2002;Smuck et al, 2011). Five studies mentioned reliability and validity but no data were presented (Briggs, 2008;Coffey et al, 2011;Cusack et al, 2004aCusack et al, , 2000bJones et al, 2004;Oddone et al, 1995;Penberthy et al, 2012).…”