Tomorrow’s Patient-Centric Trials are Here Today

David Vulcano

David M. Vulcano, LCSW, MBA, CIP, RAC, VP for Research Compliance & Integrity, HCA Healthcare

Ready or not, patient-centric trials fueled by technology and new best practices are here to stay, says David Vulcano, LCSW, MBA, CIP, RAC, vice president for Research Compliance & Integrity with HCA Healthcare. “We’re building the plane while it’s flying,” he notes.

The COVID-19 pandemic has forever changed the way clinical trials are going to be conducted, Vulcano believes, beginning with greater usage of decentralized clinical trial (DCT) tools and technology. “Patients are demanding the infrastructure be built around them” after technology demonstrated it could bring many aspects of clinical trials to a patient, rather than forcing them to come to a brick-and-mortar site every step of the way, he says.

Trials in a post-COVID-19 world will be increasingly patient- and not site-centric, Vulcano says. “Patients will want to keep much of that choice,” he notes, especially the ability to use FaceTime and other remote technologies to communicate with clinical trial professionals and other healthcare workers.

With privacy and security regulations relaxed during the pandemic to help maintain critical trials and care, Vulcano thinks patients won’t want to lose those new ways of participating in studies. “When the [pandemic] is declared over, will [regulators] tighten those regulations again?” Vulcano asks. “Patients will want to keep” the convenience and option of remote communication, he believes.

Regulators will need to work with industry to find effective ways to ensure patient safety and data integrity when using remote tools, Vulcano says. “There are privacy and security concerns, and we have to think about how principal investigator oversight and adverse events are handled, among other issues,” he adds.

Ready…Fire!…Aim. How We Got Through the Pandemic and What’s Next

Join Vulcano at ACRP 2022 on Saturday, April 23 as he gives an overview of how the pandemic forced many sites into decentralizing their studies and the effects on site cash flow, workforce safety, and increased flexibility. Examine how we can all help each other through these challenges, and how we as a workforce can maintain compliance while working in a remote environment.

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The clinical trial industry is moving from the “Blockbuster to the Netflix model,” Vulcano says. In the old days, going to a brick-and-mortar site was about the only way to rent certain kinds of new entertainment content, but Netflix and others adapted that model to offer consumers different ways to get what they wanted without leaving their homes. “I can still get a DVD in the mail or Redbox or Walmart or other places, but I can also get it streamed to my phone while I’m home or traveling,” Vulcano says.

While he’s optimistic about this future, he notes it will put new demands on the clinical trial workforce, too. For example, it will require greater familiarity with using technology and remote tools, he says. “We’re also going to see new technology and new technology partners” become a more important part of the clinical trial delivery ecosystem, he explains.

“I can’t imagine us going back” to the way clinical trials operated before COVID-19, he says. “These trends were already here—COVID-19 just accelerated them.”

Author: Michael Causey