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Fish-bones and 5-Why’s: The Secret to Troubleshooting Clinical Trials


The all-too-familiar symptom of a typical clinical trial: enrollment is falling behind. The immediate temptation: Let’s do more advertising!

The result: a lot of time, money and effort wasted and no change in enrollment. Why? Because the project team failed to conduct a root cause analysis to uncover the root cause of the enrollment problem. As a study rescue and rejuvenation specialist, I call upon the basic 5-Why’s methodology developed by Taiichi Phno, the architect of the Toyota Production System. He described the method of repeating the “Why” question five times to any challenge to uncover the core root cause and the solution will become apparent.
Problem: Enrollment is behind
1st Why? Site is not implementing their recruitment action plan
2nd Why? There is no expectation set, nor accountability for delivering on the plan
3rd Why? The CRAs don’t formally follow-up on the plan
4th Why? CRAs are not comfortable fulfilling this role?
5th Why? CRAs have not been trained on how to be a “recruitment coach”

Solution: Instead of spending resources on advertising and awareness campaigns, invest in a training program for the CRAs so they hone their skills on managing site level recruitment plans.

Of course, this is but one of >150 potential root cause issues for the poor enrollment problem but illustrates how asking “Why” can lead to a different and more effective solution than just treating the immediate symptom.

Fishbone, cause-effect or Ishikawa diagrams and 5-Why’s go hand-in-hand…they are a way to visually map out the many potential causes for a problem. By visualizing the relationship of the causes and effects the potential solutions become more obvious.

So next time you are faced with a clinical trial performance problem, challenge yourself to ask Why 5 times and you may be pleasantly surprised that you can find a simpler, more cost-effective solution to get your trial back on track.