The applicability of Lean and Six Sigma techniques to clinical and translational research.
BACKGROUND
Lean and Six Sigma are business management strategies commonly used in production industries to improve process efficiency and quality. During the past decade, these process improvement techniques increasingly have been applied outside the manufacturing sector, for example, in health care and in software development. This article concerns the potential use of Lean and Six Sigma in improving the processes involved in clinical and translational research. Improving quality, avoiding delays and errors, and speeding up the time to implementation of biomedical discoveries are prime objectives of the National Institutes of Health (NIH) Roadmap for Medical Research and the NIH's Clinical and Translational Science Award program.


METHODS
This article presents a description of the main principles, practices, and methods used in Lean and Six Sigma. Available literature involving applications of Lean and Six Sigma to health care, laboratory science, and clinical and translational research is reviewed. Specific issues concerning the use of these techniques in different phases of translational research are identified.


RESULTS
Examples of Lean and Six Sigma applications that are being planned at a current Clinical and Translational Science Award site are provided, which could potentially be replicated elsewhere. We describe how different process improvement approaches are best adapted for particular translational research phases.


CONCLUSIONS
Lean and Six Sigma process improvement methods are well suited to help achieve NIH's goal of making clinical and translational research more efficient and cost-effective, enhancing the quality of the research, and facilitating the successful adoption of biomedical research findings into practice.
Schweikhart
Sharon A
SA
Center for Health Outcomes, Policy, and Evaluation Studies, Center for Clinical and Translational Science, College of Public Health, The Ohio State University, 174 18th Avenue, Columbus, OH 43210, USA. sschweikhart@cph.osu.edu
Dembe
Allard E
AE
D000818:Animals; D035843:Biomedical Research / Q000458:organization & administration*; D017598:Efficiency, Organizational; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000458:organization & administration; D010561:Personnel Staffing and Scheduling / Q000458:organization & administration; D011785:Quality Assurance, Health Care; D012308:Risk Management; D017751:Safety Management; D017749:Total Quality Management; D057170:Translational Research, Biomedical / Q000458:organization & administration*; D014481:United States