The Scope of Things: Craig Lipset on Decentralized Trials, the New Risk Model, and Open Doors
By Allison Proffitt
April 5, 2022 | The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry’s understanding of risk.
Innovation can be hard to adopt, he tells Deborah Borfitz, Clinical Research News senior writer and host of the new Scope of Things podcast. Before the pandemic, adopting decentralized approaches to clinical trials meant pulling in new tools for trial conduct that required review and adoption from compliance and regulatory teams, not to mention sites, sponsors, and more.
But risk mitigation we adopt in earnest, he points out. During the pandemic, the environment was suddenly much more risky than these tools. Decentralized approaches to trials became counter measures to the risky pandemic when patients couldn’t travel to sites. Now most major sponsors have embedded these changes into their organizations, Lipset observes, and because change is an involved process in large and complex organizations, he predicts that these adoptions will outlast the pandemic.
While Lipset is a strong proponent for decentralized trials—he was involved in Pfizer’s pilot of the concept more than twenty years ago—he does not advocate an “all or nothing” approach. Hybrid approaches are not a compromise, he says. The goal isn’t to get rid of brick and mortar trial sites; patients overwhelmingly report liking their experiences with investigators. They just can’t always get there.
The decentralized trial toolkit is diverse, Lipset says, including telemedicine, retail pharmacies, pop up sites, working with local community doctors, home visits, digital monitoring, and more. “Decentralized” is an umbrella term, he argues, that encompasses both processes and technology—not just a lot of tech. A decentralized approach will impact how and where people participate, prioritizing flexibility, diversity, and expanding accessible geographies.
The goal, Lipset repeats, is not to close doors—limiting options—but to open more doors.
He admits that this is hard to operationalize. The toolkit can be used differently at different stages of the trial, he adds. Perhaps first visits are in person, visit 3 can be completed one of several ways, but visit 4 needs to be back in the clinic. And different patients may choose to engage in different ways. Thus the protocol for one visit may need to outline steps for visiting nurses plus site visits plus video options. But the truth is this is how we all, as consumers, engage with the world. We want choice.
Lipset and Borfitz discuss the regulatory response to decentralized approaches and what roadblocks to watch for. There is still work to do, Lipset says. He highlights data flows that still need to be “fully baked” and the management aspects of ensuring home health consistency. But he is overwhelmingly hopeful. Easily 80% of our clinical trial portfolios will benefit from some aspect of decentralized trials, he says.
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior Writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.