title: 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.
authors.affiliation: Clinical Trials Office, University of Michigan Comprehensive Cancer Center, 1500 East Medical Center Drive, 6316 Cancer Center, Ann Arbor, MI 48109-5942, USA.
authors.forename: Pam
authors.initials: P
authors.lastname: James
authors.forename: Patricia
authors.initials: P
authors.lastname: Bebee
authors.forename: Linda
authors.initials: L
authors.lastname: Beekman
authors.forename: David
authors.initials: D
authors.lastname: Browning
authors.forename: Mathew
authors.initials: M
authors.lastname: Innes
authors.forename: Jeannie
authors.initials: J
authors.lastname: Kain
authors.forename: Theresa
authors.initials: T
authors.lastname: Royce-Westcott
authors.forename: Marcy
authors.initials: M
authors.lastname: Waldinger
mesh_terms: D002017:Budgets / Q000379:methods / Q000592:standards*; D002138:Calibration; D002986:Clinical Trials as Topic / Q000191:economics* / Q000592:standards* / Q000706:statistics & numerical data / Q000639:trends; D003191:Comprehensive Health Care / Q000191:economics / Q000458:organization & administration / Q000592:standards / Q000706:statistics & numerical data; D003365:Costs and Cost Analysis; D003627:Data Interpretation, Statistical; D005376:Financial Management; D006801:Humans; D008824:Michigan; D017059:Models, Econometric; D009369:Neoplasms / Q000191:economics* / Q000628:therapy*; D017064:Process Assessment, Health Care; D012107:Research Design; D016526:Workload / Q000592:standards