Is it Time to Reexamine the Barriers Between Drug and Device Trials?

Lisa Haney, BS, CCRC, Director of Research, Nura Research Institute

Organizational barriers and silos—both real and imagined—hamper clinical trial performance in a number of ways. While some obstacles are probably inevitable given the complexity and breadth of conducting a trial, in some regrettable cases the industry gets in its own way with outmoded views and operating procedures.

For example, the stale and arbitrary belief that two years of experience are required before a clinical research coordinator (CRC) can move forward is a “fallacy” placing an artificial lid on the prospective new talent waiting to help address a chronic workforce shortage, says Lisa Haney, BS, CCRC, director of research at Nura Research Institute.

Another “unforced error” is the false perception that drugs and devices are fundamentally different when it comes to clinical trials. Of course, there are nuances, Haney says. However, they have a lot more in common when it comes to the demands required by each, including following similar good clinical practices, human subject protections, and federal regulations requirements, Haney says.

“They may be apples and oranges on the surface,” Haney says, but drug and device clinical trials at core demand the same type of highly qualified clinical research practitioners. Unfortunately, there’s a stubborn perception in the trial landscape that someone who shows talent working within one of these realms of product development can’t necessarily thrive working within the other, Haney says. She’s seen it firsthand when trying to make new hires.

“At first I didn’t realize there was such a widespread view that there was such a rigid difference” between working in the two worlds, Haney says. However, clinical trials are suffering because of it, she adds.

Research is as Research Does: Does Drug of Device Experience Really Matter?

Join Haney at the ACRP 2020 annual conference in Seattle, May 1-4, as she addresses the difficulties clinical researchers face when either presented with an opportunity to cross over from drug to device studies and vice versa, or a sponsor takes the leap of faith and hires a professional to a device(or drug) company when they have several years of drug(or device) experience and no years of device( or drug) experience.

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Haney is hoping to share her experiences demonstrating that a good clinical researcher is a good clinical researcher, regardless of whether it’s a drug or device trial in question. “I want sponsors and CRCs to think outside the box” more when considering moving between drugs and devices in their professional careers, she says.

While a tight job market is one factor to consider, for Haney it’s also a recognition that drug/device combination products are on the rise. It’s time to view clinical research as a skillset and worry less about the relatively small distinctions between device and drug trials for the betterment of patients and industry, she says.

Author: Michael Causey