Wednesday, January 28, 2015

Five Steps for Improving Processes in Clinical Trials

Author: John R. Wilson, Jr., PhD, MPH, is Senior Vice President at Beaufort, LLC.

Nobody would accuse the clinical research enterprise of being a paragon of efficient processes. It’s not that we don’t want our processes to be efficient; it’s just that the work needs to get done, no matter how inefficient the current processes are. After an initial burst of enthusiasm, process improvement projects seem to lose steam and then are quietly set aside for more pressing priorities.

The good news is that there is a proven, five-step process for improving business processes. This article will provide an introduction to the five steps, using risk-based monitoring (RBM) as an illustrative example.

But first, let’s define what we mean by “process.” In essence, a process is a standardized series of steps taken to achieve a goal. Processes simplify, streamline and regulate our activities. Formal processes are known as procedures (“standard operating procedures (SOPs)”), with well-documented steps. In our business, procedures are frequently designed to comply with governmental regulations and guidelines. Informal processes, on the other hand, just seem to exist as customary practices that are passed along by word of mouth, along with the forms and other artifacts of the process.

The Japanese method of kaizen (continuous improvement) is not limited to incremental changes. Sometimes, major changes are required to fix an obsolete or broken process. RBM, for example, requires major changes that cannot be implemented in tiny steps. Successful organizations must therefore be able to make major process improvements.

The five basic steps to significantly improve a process are: (1) map, (2) analyze, (3) redesign, (4) assign resources, and (5) implement improvements. Only after completing the first four steps can we productively move on to the fifth step, in which a process is actually improved.

For details, see John Wilson's article, “Five Steps for Improving Processes in Clinical Trials,” in the Journal of Clinical Research Best Practices.

This article is presented by Partnerships in Clinical Trials partner The Journal of Clinical Research Best Practices.  PCT will take place April 22-24, 2015 in Boston,  As a reader of this blog, when you register to join us and mention code XP2000LI, you can save $100 off current rates.

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