A Mayo Clinic project to eliminate wastes from the traditional system of protocol development has reduced turnaround time for clinical trials by 60 percent, as reported online in the June 29 issue of Journal of Clinical Oncology.
The time needed for protocol development shrank from 25 to 10 weeks for internally authored protocols, and 21 weeks to 8 weeks for externally authored protocols.
Lead author Terre McJoynt, Coordinator of Research Operations, Mayo Clinic Cancer Center Clinical Research Office, reported that the Mayo team used the Define, Measure, Analyze, Improve, Control (DMAIC) framework combined with Lean waste-reduction methodologies to identify and rectify problems in the protocol process.
The project was conducted across all Mayo campuses. The group examined the process from the time of a completed protocol though submission to the Mayo Institutional Review Board or other approving authorities such as the National Cancer Institute. After critically examining the existing protocol development process, the Mayo team designed and implemented improvements and efficiencies to the protocol development process resulting in significant reduction in the time needed to deliver protocols for review.
The Mayo team contributing to this project included Ms. Mc Joynt and colleagues Muhanad Hirzallah, Mayo Integrated Research Information System; Daniel Satele, Biomedical Statistics and Informatics; Jason H. Pitzen, Systems and Procedures; Steven R. Alberts, M.D., Medical Oncology; and S. Vincent Rajkumar, M.D., Hematology.
Here are links to the abstract and article:
Abstract
Article
