Applying the Power of Performance Analytics to the Challenge of Improving Clinical Research

Peter Malamis, CEO, CRO Analytics

Peter Malamis, CEO, CRO Analytics

ACRP recently announced a joint initiative with CRO Analytics, Inc. to provide clinical research organizations with insight on performance analytics and its role in improving clinical research. Through the initiative, called ACRP Analytics, ACRP and CRO Analytics will assist ACRP Members and their employers in understanding and employing rigorous service quality measurement to reduce the costs and timelines of clinical trials. We talked with CRO Analytics CEO Peter Malamis about performance analytics and the partnership.

Why is the ACRP Analytics collaboration between ACRP and CRO Analytics something our members should be excited about?

Malamis: It’s exciting because the ACRP Analytics initiative holds the power to revolutionize the clinical research environment. The collaboration enables members and their companies to take advantage of two simple but powerful tools the industry is just beginning to embrace – rigorous service quality measurement and predictive modeling. The resulting performance analytics shows for the first time what really drives KPI’s and what specifically needs to be addressed to minimize costs and missed deadlines. We’ll be presenting this in more detail through a series of webinars starting soon.

In the meantime, we posted a White Paper titled Applying the Power of Performance Analytics to the Challenge of Improving Clinical Research that can be downloaded now.

What are “performance analytics?”

Malamis: Performance analytics is the term we use for the data associated with analyzing clinical trial performance based on service quality measurement. We find it helps distinguish these metrics from more traditional “operational metrics” or “key performance indicators.”

Why is this distinction important?

Malamis: The distinction is real and important. Operational metrics can be thought of as the symptom while performance analytics are the diagnosis. The symptom tells you what’s happening, the diagnosis tells you why. That’s the reason we say that performance analytics data is the “why behind the KPI.”

Think of your typical CTMS data-driven heat map. It shows you’re behind on enrollment or that your query rate is too high – those are symptoms. To properly treat the symptom you need to understand what is causing it – the diagnosis. Operational metrics aren’t designed to and never will be able to do that. They can’t tell you “why,” only “what” because they are typically only measures of things like time and quantity. To continue the medical analogy, think of pain in your shoulder. Is it a pull, a tear, a break, a bug bite? You may think you know but you can’t be sure and being wrong can have major consequences.

That makes a lot sense so why do you think this approach hasn’t been used before?

Malamis: Three reasons. First, at its heart, a clinical trial is a service not a product. Pharma companies were built as product companies not service companies so it makes sense culturally that the product perspective dominates. Products can rely on operational metrics like defect rates as an indication of quality, services can’t because of the symptom vs. diagnosis issue and because assessing service quality is highly personal.

Last, while it’s a simple concept because of the preceding reason and others, that doesn’t mean adoption and acceptance is easy. It’s only recently that CTMS and other operational systems have begun yielding the “symptom” data in a user-friendly way against which performance analytics can be applied. In addition, the growth of site-centric and patient-centric thinking was a necessary precursor to wanting

It’s not surprising that If understanding the key drivers of that service and how they are performing can tell you the “why.” As we all know, once you have the proper diagnosis, treating the underlying issue is more likely to be successful.

So why collaborate with ACRP on this?

Malamis: The collaboration is exciting because literally everything about ACRP and its members is about improving quality. The training, the myriad of resources, certification, webinars, and special initiatives are driven by the philosophy that quality matters and with constant improvement as the goal.