January 25, 2021 | Nothing quite tests a risk-based management approach like a global pandemic that few predicted. And for Pfizer’s Melissa Suprin, the COVID-19 pandemic was the first big test of the  quality management system.

“We looked at the pandemic as an external factor that had the potential to influence many of our processes,” Suprin said. She and her team reviewed both the risk assessments that were already in place for clinical research processes as well as the new risks arising from pandemic response. “In general, we found that the processes we had in place in our quality management system were still applicable,” she said.

Suprin is responsible for the processes and systems that Pfizer uses to manage risks, and she applies her background in chemical engineering and business administration to clinical development there.

On behalf of Clinical Research News, Bridget Kotelly spoke with Suprin about managing risks versus issues, Pfizer’s approach to the challenges, and weathering the pandemic.

Editor’s note: Suprin will be speaking at SCOPE, the Summit for Clinical Ops Executives on Tuesday, March 2 in Risk Based Quality Management program.

Clinical Research News: What do you feel are the greatest challenges that you're facing when it comes to risk based quality management in clinical trials today?

Melissa Suprin: I've seen three challenges through my work at Pfizer and as the lead of TransCelerate Quality Management System team. The first one is that our industry is practiced at managing issues, and while risks and issues are related, they're not managed the same way. And I think we're still learning that as an industry. So issue management has the certainty of something having already gone wrong and risk management is trying to predict what could go wrong.

Like maintenance on a car or any other piece of equipment, preventative activities can be misunderstood until they're omitted and something fails. Maintaining the brakes on a car prevents accidents, but it's hard to see that if you always keep your brakes maintained and never have an accident. Risk management is a much less exact science and harder to measure, but it has the potential to be more impactful to participant protection and the reliability of trial results because of its preventative nature.

A second challenge—or maybe an opportunity—is leveraging the full benefit of risk management in the context of a larger quality management system. As the pharmaceutical industry matures beyond managing elements of a quality management system separately, hopefully we'll become more and more adept at leveraging the relationships among the connected elements of that system.

To give a couple of examples, quality culture influences the attitudes and approaches to all the other quality management system elements. Issue management informs risk management. Where you have a bunch of issues that would be an opportunity to look for, is there something preventative that you can do? Similarly, process design and improvement can be informed by both issue and risk management. So as our quality management systems mature, I think there's an opportunity to better leverage those connections. And again, that's kind of as an industry in general.

And finally, the concept of risk proportionality has come a long way, but still has a way to go. Applying resource where it will have the largest impact on what matters most requires defining upfront what's most important, and using that to inform when, whether and how downstream process controls are applied. So that practice takes practice and it takes time to see the benefits of using that preventative approach, but well implemented results in fewer issues in downstream processes.

How is Pfizer addressomg these challenges?

Good question. In clinical development, we've been on a long journey of implementation and cultural change. That doesn't happen overnight. And there have been adaptations through many changes and challenges both internal and external, but it started simple with just establishing a risk management process at the study level many years ago, and has matured to include clinical development as well. Like many early implementations, risk management started in Excel tools and templates, and is now supported by technology and data. That helps us do a better job of predicting and managing risks.

We've introduced some predictive elements that we hope to continue to enhance over time as the technology further develops. That would be my advice to companies or vendors or others who are just starting with a risk management process: start with those simple approaches. It doesn't have to be fully mature when you first start, but focusing on what matters most and applying resources in a proportional way is a great place to start.

From a Pfizer perspective, that took us some time, but over time, the organization has gotten more adept at managing risk. It started from helping people understand the difference between issues and risks. And we now see more and more contributors to clinical trials with skills in and understanding of risk management. We’ve had the opportunity to test our processes when faced with unexpected challenges and changes. And we now see vendors providing clinical trial services that understand the importance of managing risks for trials. It's to their benefit: to the sponsors’ benefit, and more importantly, it's to the benefit of trial participants. I'm happy to see that progress across the industry. I think that's the journey Pfizer's been on for a long time, and we'll continue to work at maturing that and leveraging the technology and the data that are out there to support it.

I know this might be a big question, but how did your risk management processes work through COVID?

It's a great question. I think much to our relief they did work through COVID. So that was the first really big test we've had of our whole quality management system. I think the good news is that the concepts still apply. We looked at the pandemic as an external factor that had the potential to influence many of our processes. And so took the opportunity to look at the risk assessments we had in place for some processes and for studies to see what changes that the pandemic had and also the changes that we were making in response to the pandemic and including those kind of risk assessments as well.

It wasn't simple or small; nothing about the pandemic has been. But in general, we found that the processes we had in place in our quality management system were still applicable. They needed to be invoked and applied to that situation, but they were helpful in things like identifying risks that were out there, evaluating them relative to their impact on  participant protection, reliability of trial results, and documenting those and implementing controls where appropriate, specific to the risk management space.