Adapted from the NCI Cancer Bulletin, vol. 6/no. 14, July 14, 2009 (see the current issue).
By streamlining the development process for clinical trial protocols, the Mayo Clinic Cancer Center reduced by approximately 40 percent the time from the initiation of protocol to submission of the document to an institutional review board (IRB) for approval. Results of the initiative were reported June 29, 2009, in the Journal of Clinical Oncology (see the journal abstract).
Cancer clinical trials with prolonged activation times have been shown to have less success in meeting patient accrual goals. Such failed trials may delay getting potentially beneficial new cancer treatments to patients.
Mayo investigators and protocol development staff used Six Sigma, an improvement process developed and widely used in industry, to analyze where time was spent during protocol development and how process changes could reduce delays. They found that of a total of 199 days required to finalize a trial protocol, 174 days were “non-value-added”—that is, days spent waiting for something to happen (e.g., a revision, a response to a question, a document signature).
By introducing a standard template for all clinical trial processes and making other process changes, such as identifying steps that could be completed concurrently rather than sequentially, the cancer center reduced the “turnaround time” (that is, the time from initiation to IRB submission) from 25 weeks to 10 weeks for internally authored protocols and from 20.6 weeks to 7.8 weeks for externally authored protocols.
The experiment showed that significant progress can be made “in decreasing protocol development [turnaround times] through focused process engineering,” the authors, led by Terre A. McJoynt of the Mayo Clinic Cancer Center Research Office, wrote. “Such improvements can be realized within an extremely short timeframe and with little or no incremental investment in administrative resources.”
The group is now undertaking a second phase of the improvement effort, which will focus on the entire protocol development time from study concept through patient enrollment.
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