Blazing a New Trial
Cancer Center Clinical Trials Office goes lean
(Sept./Oct. 2008)
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The Comprehensive Cancer Center Clinical Trials Office implemented lean strategies to reduce the amount of time between receiving notification of a clinical trial and approval to enroll the first patient from around 200 days to about 150. Front: Jeannie Kain, Theresa Royce-Westcott, Cari Krzyzaniak, Linda Beekman, Mary Louise Good, Dennis Cooperson, Monica Orians, Janet Tarolli, Tina Wilbee. Back: Kristen LaVasseur, Matt Innes, Shelagh Elliot, Ffabian Rollins, David Browning, Pam James, Marlon Wardlow.
In addition to reducing waste in time or materials, going “lean” improves staff satisfaction and customer service. Just ask Linda Beekman, R.N., M.B.A., administrative director of clinical research for the Comprehensive Cancer Center Clinical Trials Office.
“There were delays in the activation of new studies and we didn’t always know where things were in the process. We wanted to streamline what we were doing to improve customer service to research teams,” says Beekman.
Along with Marcy Waldinger, Cancer Center chief department administrator, David Smith, M.D., CTO director, Marlon Wardlow, lean coach, and the Cancer Center CTO management team, Beekman implemented lean strategies to reduce the amount of time it takes to activate a trial (the time between receiving notification of a clinical trial and approval to enroll the first patient).
The Changes
The Cancer Center CTO now starts each trial with a feasibility meeting— a meeting in which regulatory, finance and data management staff meet to discuss various aspects of trial conduct and identify potential obstacles with respect to budgets, space, IRB approval and equipment needs.
The team also created an online database that staff can access to find out exactly what is happening in the trial, and keep the principal investigator and study team informed of the project’s status.
Calendars are being developed for all new studies, enabling the data managers and study teams to know when required testing is to be performed, and ensuring study compliance. This also will streamline billing and potentially reduce protocol deviations.
The Results
The gains achieved by the process were significant. Beekman estimates that lean processes may have saved approximately $260,000 in new staff hires, while noticeably improving staff morale and greatly reducing the lead time needed to get a trial up and running. She notes that her office has achieved about a 25 percent reduction in the timeline. What used to take around 200 days now takes about 150—and the gap is continuing to close.
This effort is one of the first Michigan Quality System projects dealing with research and one of more than 70 MQS projects under way in various Health System units and departments in the past year.