Systems and Regulatory Issues

Guest Expert Marge Good: Clinical Trial-Associated Workload--how to quantify the work?

Last Updated: Apr 24, 2013

A big welcome to this month's guest expert, Marge Good, RN, MPH, OCN. Marge is a Nurse Consultant in the National Cancer Institute's Division of Cancer Prevention where she provides support to over 60 Community Clinical Oncology Programs (CCOP) and Minority-Based CCOPs. Marge came to her position at the NCI with great credibility-- over 20 years experience as the manager of the Wichita CCOP.  Assessing clinical trial-associated workload has been a long held interest for Marge.  Her efforts recently culminated in a Journal of Oncology Practice publication, “Measuring Clinical Trial-Associated Workload in a Community Clinical Oncology Program”.  


From Marge:

One of the more frequently asked questions I heard during my years of cancer research experience, particularly while functioning as a research manager, is “How many clinical trial participants or patients should a research nurse or research staff person be able to manage?”   No one seems to really know the answer and therefore many research managers base staffing decisions on subjective information such as their research staff telling them “they are too busy and overworked”.


There have been some efforts to build tools that can measure clinical trial-associated workload; however, many of the tools thus far are labor intensive requiring the documentation of time taken to complete various research-related tasks and as those of us who work in cancer research know, the tasks are many. 


The JoP artlicle mentioned above describes a workload assessment tool utilized for approximately 11years in a busy CCOP which helped to inform management of the need to hire additional staff or to make adjustments in work assignments based on workload.  The workload calculation was based on complexity of individual trials in conjunction with the number of patients being managed by individual staff.   Trial complexity or acuity levels were assigned to each trial according to a four-level tiered assignment (a score of “1” being less complex than a score of “4”). 


ASCOs Cancer Research Committee has responded to the ASCO membership by committing time and effort towards further testing of a workload tool utilized in the CCOP setting.  Community-based research programs have been solicited for participation in a project to assess their individual research program’s clinical trial workloads utilizing the tool which has been developed into a web-based reporting mechanism.   Data will be gathered over approximately 6 months from a minimum of 50 research programs.  At the conclusion of the project ASCO hopes to have preliminary benchmark data regarding clinical trial-associated workload.  This would be a much needed answer to this long unanswered question. 


Does your research program assess workload (e.g., number of patients per research nurse or CRA)?  Share with us how you do it and look for ASCOs results in the near future for workload assessment. 

Please Login or Register to post comments.