Rising Patient Expectations to Roil Clinical Trial Landscape

David Vulcano headshot

David M. Vulcano, LCSW, MBA, CIP, RAC

Today’s healthcare patient tends to expect delivery of services more on their terms than at any time in recent history, experts say. Whether it’s the use of wearables to track healthcare data, leveraging virtual clinical trials, or diagnosis via telemedicine, patients, especially millennials, won’t always jump through the same hoops to employ the services of a provider or clinical trial.

“Patient expectations are very different” and that’s only going to become a bigger factor in the years to come, says thought-leader David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity HCA Healthcare. The “convenience factor” for patients has never been more important to address in clinical trials, he notes. “It’s a different paradigm for sites, with remote visits” and other more flexible service offerings demanding new skills of clinical trial service providers, Vulcano says.

When Vulcano looks in the crystal ball, he sees a changing clinical trial landscape. “The guts and core of clinical trials aren’t changing rapidly, but the peripherals certainly are,” Vulcano says. Patient expectations is just one example of a new frontier.

2020 Annual Update of Things Affecting Our Industry

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He anticipates some interesting new wrinkles on the U.S. Food and Drug Administration (FDA) regulatory front. “There’s lots of movement in the pre-approval process, right to try, and expanded access,” he says. The agency “is making it a heck of a lot easier for patients to get” access to certain drugs and treatments. “I hate to use the word competing, but those [options] are different pathways for patients to access drugs rather than through clinical trials,” he notes.

Vulcano is also excited about how blockchain and machine learning may impact clinical trials in the future. And while some of the inner workings of each will no doubt evolve, the basic concepts won’t change much. “Unless you are a cryptographer or coder, what you learn about both” will be relevant information for a long time, Vulcano says. “Operationalizing these technologies won’t be obsolete in three months,” he adds.

Allowing industry is still “dabbling” in both blockchain and machine learning, Vulcano says investigating them are still worth a little time to the savvy clinical trial practitioner.

Author: Michael Causey