Quality Is Never An Issue, Until It Becomes An Issue

By Ed Miseta, Chief Editor, Clinical Leader

I don’t spend a lot of time thinking about quality. I doubt that most consumers do, even when purchasing pharmaceutical products. I have leg pain for which I take Ibuprofen almost daily. I also have a prescription medicine I take once a day. Even for these products, which could easily affect my health and well-being, I do not stop to consider the manufacturer, country of origin, or most importantly, whether it was manufactured by a company with a focus on quality. Like most consumers, I just assume it [quality] is there.

HOW DO YOU DEFINE QUALITY
In the world of outsourced clinical trials, you are purchasing a service, not a product. But the result of a trial conducted with poor quality could be even more disastrous: a blown study, an FDA rejection of your data, or worse … an injured patient.

One of the first books I read on quality was Zen and the Art of Motorcycle Maintenance by philosopher and novelist Robert Pirsig. In the words of Pirsig, any philosophic explanation of quality is going to be both false and true precisely because it is a philosophic explanation. “What I mean (and everybody else means) by the word ‘quality’ cannot be broken down into subjects and predicates,” he states. “This is not because quality is so mysterious but because quality is so simple, immediate, and direct.”

But is that always the case? If I eat a great meal in a great restaurant and get great service, I will tell my friends and family, “That is a quality establishment.” The quality seems simple, immediate, and direct. But are their coolers at the right temperature? Are there rodents under the counters? Are employees washing their hands? I have no way of knowing. Similarly, if a CRO completes your study on time, to your specifications, and meeting all regulatory requirements, they have certainly served your needs well. Unfortunately, there could be quality issues looming that may very well sink your next study. How would you know?

IDENTIFY, MEASURE, AND MONITOR
So how do you identify quality in a CRO? How can you tell if they have a culture of quality or if it matches your own? Is there a way to measure and monitor it on an ongoing basis? These are questions that many clinical executives struggle with daily.

In this edition of our annual CRO Supplement, we take a look at the issue of quality in clinical trials. Mike Howley, associate clinical professor at LeBow College of Business at Drexel University, discusses the research he has performed on measuring quality in trials (page 28). According to Howley, if you’re measuring it, you’re probably doing it wrong. I hope you will find benefit in this article and the others we have produced for this supplement.

In an industry where medical products are digested by or injected into human trial subjects, quality has to be on the minds of everyone. Or as Pirsig so eloquently put it: “My personal feeling is that this is how any further improvement of the world will be done: by individuals making quality decisions and that’s all.”