The Challenge
by Antonio Rodriguez (N.I.H.)
As presented at the 2018 Winter Simulation Conference
Even the best scientific minds cannot repeatedly produce desired results when working in sub-optimal systems...
Introduction
The continued development of computer modeling and simulation (CMAS) products have facilitated new capabilities...
The clinical research (CR) field is complex and could benefit from the application of CMAS...
Discussion
In a tight fiscal or highly competitive environment, efforts to accomplish critical enterprise results...
Inadequate capacity throughout the sequence of activities and decisions will cause unnecessary delays...
Like the private sector, federal government is frequently challenged by limits in budget and human resources...
However, even in manufacturing facilities the problem of unbalanced processes or activities caused the cost...
Knowing what is needed to produce a product is necessary, but not sufficient...
Consistent efficiency and effectiveness are a function of multiple factors...
Production Schedule
CMAS is an excellent tool to model different scheduling scenarios quickly to inform decision-makers...
Quality
Many have attempted to define quality. It is difficult to do...
Shewhart examined the subject of quality from different perspectives...
Process quality impacts production capacity...
Without consistent quality upstream, enterprise resources will be consumed...
Clinical Research
The process of making important discoveries that improve health and save lives is lengthy and complex...
The translation of basic biological discoveries into clinical applications that improve human health...
Since this overall translational effort is a complicated progression...
As applied to CR, what is the meaning of quality?
The NIH is expected to make important discoveries that improve health and save lives...
What are the results expected from the CR enterprise?
As in manufacturing, the CR support system is also complex...
Professionals depend upon laboratory and hospital equipment...
What and how many of each type of resource is needed throughout the steps of the process?
In addition, the CR system depends on scientists with outstanding credentials...
Optimizing every function independently seldom achieves overall net optimization...
The Solution
Approach
What follows is not a cookbook, but a methodology...
First CR needs to be recognized as a sequence of interdependent steps...
In an actual model, more granularity would be needed...
CMAS can account for important performance indicators...
Once the model is tested and demonstrates that it is valid and reliable...
The approach discussed here is thorough, complex, and somewhat time consuming...
The Business Impact
Conclusion
Traditional improvement efforts are usually focused on components of systems...
Author Biography
Antonio R. Rodriguez is the director of the Office of Quality Management...
References
Ackoff, R. L. 1994. The Democratic Corporation.
Christopher, W. F., and C. G. Thor. 1993. Handbook for Productivity Measurement.
Collins, F. S. 2011. Reengineering Translational Science.
Dagalar, S. 2016. CTMS: What You Should Know.
Deming, W. E. 1986. Out of the Crisis.
Deming, W. E. 2000. The New Economics.
Juran, J. M. 1989. Juran on Leadership for Quality.
Mahon, E. et al. 2016. Barriers to Trial Recruitment.
Lewis, C. I. 1929. Mind and the World-order.
Pegden, C. D. 2017. Deliver on Your Promise.
Porter, M. E., and E. O. Teisberg. 2006. Redefining Health Care.
Shewhart, W. A. 1931. Economic Control of Quality.
Simio Forward Thinking. 2018.