Automation. Technology. Innovative thinking.
Creative minds at City of Hope are coming up with new ideas — ideas for change intended to support City of Hope in its aspiration to become the premier cancer center in Southern California and rank it among the top cancer centers nationally by 2013.
 Work by “Wave 1” participants led to capital savings that were spent on investments such as the Michael Amini Transfusion Medicine Center, under construction. (Photo by p.cunningham) |
Dozens of faculty and staff members are riding a “wave” of inspiration. They are participating in efforts called Wave projects, key initiatives crafted to help realize the strategic plan.
“The faculty and staff in the research community provided very specific feedback about our areas of strength and opportunity that resulted in launching these specific Wave projects,” said Robert Figlin, M.D., interim director of the cancer center and Arthur and Rosalie Kaplan Professor of Medical Oncology.
In particular, he highlighted the Clinical Research Regulatory Approval project, which aims to improve how clinical trial studies undergo regulatory review and approval. “This project is an excellent example of turning faculty and staff input into action to meet our institutional needs,” Figlin said.
The first Wave projects, or Wave 1, began in 2006 and are scheduled for completion in 2009. These highly successful projects focused on improving productivity to release capital for strategic investments. Those investments are becoming a reality. They include the Michael Amini Transfusion Medicine Center, the Arnold and Mabel Beckman Center for Cancer Immunotherapeutics and Tumor Immunology, and the City of Hope Information System.
Wave 2 projects are now under way to support process improvement, with a focus on improving the efficiency, effectiveness and safety of key scientific processes.
“The faculty and staff in the Wave 2 projects are working to improve the efficiency with which we bring new discoveries and therapies to the bedside in the most effective and safe way,” said Virginia Opipare, executive vice president and chief operating officer of City of Hope and an executive sponsor (along with Figlin) of the Wave 2 Clinical Research Regulatory Approval Process Improvement Team. “This means not only an intense commitment to bringing new treatments and cures to fruition; it also means further improvement of the underlying processes that enable scientific discovery.”
The Wave 2 team aims to reduce protocol resubmissions, make innovative use of new technology and reduce the number of review cycles for submitted clinical trials.
Currently, every clinical trial receives both a scientific review and a human subjects protection review. Submissions are incredibly complex — a virtual jigsaw puzzle of information — and that means many review cycles. Committee members often have to review thick, exhaustive proposal files that contain many elements, including informed consents, methodology and potential drug reactions and risks.
 Staff and research efforts through Wave 2 will help researchers move findings from lab to clinic. (Photo by Walter Urie) |
The Wave 2 team has explored and implemented several improvement tactics in the last year. The team recommended and is beginning to incorporate standardized tools such as customizable templates to help faculty and their support staff create study proposals. It also focused on improving faculty and staff education related to conducting clinical research.
Improvement work has been aided by the Integrated Research Information System (iRIS) that City of Hope launched in 2006. This system streamlined and automated the review and management of clinical trial submissions. The City of Hope iRIS installation is considered one of the nation’s most successful such product implementations.
The Wave 2 team used the automated workflow capabilities in iRIS to improve the efficiency and quality of study submissions. The team has identified future improvements to iRIS.
The Wave 2 team’s work is yielding results. The Clinical Protocol Review & Monitoring Committee, which reviews study submissions for their scientific merit, has added more faculty reviewers so it can review submissions more quickly. Wave 2 also has decreased turnaround time for action notices — study approvals or disapprovals — sent out by the Institutional Review Board (IRB) related to human subjects protection reviews.
“The IRB meets twice a month, and the goal was to have action notices sent to principal investigators before the next IRB meeting,” Human resources professional lends expertise to health workforce summit by Diego de la Garza Opipare said. “We’re happy to report that goal has been met.”
The Wave 2 team has 22 members, but more than 100 faculty and staff contributed to the process improvement effort. The group hopes to complete the first phase of its work in early 2009. It will then tackle additional priorities such as applying for accreditation from the Association for the Accreditation of Human Research Protection Programs.
Team members include Shery Azimi, C.P.A., M.B.A., Smita Bhatia, M.D., M.P.H., Ellen Bolotin, M.D., Ph.D., Arlene Carroll, Warren Chow, M.D., Jonathan Espenschied, M.D., Robert Figlin, M.D., Michael C. Jensen, M.D., Richard Jove, Ph.D., Kristine Justus, Ph.D., Alexandra Levine, M.D., Nancy Moldawer, R.N., M.S.N., Joanne Mortimer, M.D., Virginia Opipare, Gwenn Oki, M.P.H., C.I.P., Bob Powell, M.Ed., Eileen Smith, M.D., Caroline Song, R.N., M.S.N., M.S., Doug Stahl, Ph.D., M.B.A., Jack Shively, Ph.D., Yun Yen, M.D., Ph.D., and John Zaia, M.D.