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The Applicability of Lean and Six Sigma Techniques to Clinical and Translational Research
  1. Sharon A. Schweikhart, PhD,
  2. Allard E. Dembe, ScD
  1. From the Center for Health Outcomes, Policy, and Evaluation Studies, Center for Clinical and Translational Science, College of Public Health, The Ohio State University, Columbus, OH.
  1. Received April 1, 2009, and in revised form June 19, 2009.
  2. Accepted for publication June 29, 2009.
  3. Reprints: Sharon A. Schweikhart, PhD, Division of Health Services Management and Policy, College of Public Health, The Ohio State University, 5066 Smith Lab, 174 18th Avenue, Columbus, OH 43210. E-mail: sschweikhart{at}
  4. Supported by Award Number UL1-RR025755 from the National Center for Research Resources. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
  5. None of the authors of this article have any conflicts of interests related to this project.


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.

Key Words
  • Lean
  • Six Sigma
  • process improvement
  • translational research
  • quality
  • TQM
  • CQI

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