| Effort tracking metrics provide data for optimal budgeting and workload management in therapeutic cancer clinical trials. | |
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MedLine Citation:
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PMID: 22157555 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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. |
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Authors:
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Pam James; Patricia Bebee; Linda Beekman; David Browning; Mathew Innes; Jeannie Kain; Theresa Royce Westcott; Marcy Waldinger |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of the National Comprehensive Cancer Network : JNCCN Volume: 9 ISSN: 1540-1413 ISO Abbreviation: J Natl Compr Canc Netw Publication Date: 2011 Dec |
Date Detail:
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Created Date: 2011-12-14 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101162515 Medline TA: J Natl Compr Canc Netw Country: United States |
Other Details:
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Languages: eng Pagination: 1343-52 Citation Subset: IM |
Affiliation:
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From the Clinical Trials Office, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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