Evaluating Risk in the Era of Decentralized Clinical Trials

By Allison Proffitt 

November 1, 2023 | Since the pandemic, decentralized trials have claimed the lion’s share of conversation around trial design and participant engagement. When it comes to risk-based quality management, decentralized trials can also mean decentralized control. More options for patients means more opportunity for risk.  

But this is no brave new world.  

At the Summit for Clinical Ops Executives (SCOPE) Europe event earlier this month in Barcelona, Laura Galuchie, senior director and TransCelerate program lead at MSD, was quick to point out that because the various elements that make up decentralized trials have been around for many years, the risk profile is not completely new. We have been using some of the tools now labeled decentralized trials for 25-30 years, she said, and we will keep using them. Even a phone call to a patient could be considered a component of a decentralized trial, she pointed out.  

Therefore, decentralized trials do not require new risk-based quality management processes, Galuchie said, but the mix of decentralized approaches will require new thinking. “As you’re going through your process, you’re now thinking about things you might not have thought about before,” she said, referring to the increased variety of risks inherent with multiple trial environments. “The process of thinking about the risks is going to be the same, but the specifics are going to be different, because it’s always bespoke to every protocol. Every single country has different approaches; every single site has different approaches. You have to consider all of these different elements that we may not have had to consider in the past.”  

There are horror stories, of course. Galuchi recounted a home health nurse who opted to take patient notes on the Notes app of her personal cell phone. She then went back to the site and transcribed the notes into patient record, introducing a host of data privacy and quality risks.  

Decentralized sites of care and trial methodologies emphasize the importance of continual risk re-evaluation, added Keith Dorricott, director at Dorricott Metrics and Process Improvements. “It’s not just that risk-assessment at the start; it’s that constant re-evaluating,” he said. But Dorricott argued that this re-evaluating can be an advantage. “Let’s use that to understand what the risks are and improve the growth mindset and critical thinking.”  

Galuchie echoed the value of growth mindset. “When people think about protocols, they think about how prescriptive they can be. Do one procedure then the next, the next, the next. But critical thinking—the growth mindset—reminds us that, ‘Yes, that’s important, but always say, ‘What else?’ Always think bigger than that. Think of what could happen.”  

Regulations add a layer of complexity, of course. Some of the SCOPE audience perceived a “hyper focus” on decentralized clinical trials and the varied guidances from different regulatory bodies. 

Dorricott recommended thinking about risk assessment at multiple levels and then consider risk independently at each level. “You have the corporate level, the program level, the study level,” he said. “If you try to fit everything into one risk assessment, it just becomes overwhelming, and I don’t think that’s practical.” 

Galuchi agreed. She also called for responsive risk assessment when there are change. For example, she said, if a site has a new study coordinator, plan a local risk evaluation for the new team member.