A clinical trial focused on a device is markedly different than one focused on a drug—a distinction that sometimes gets lost, warns Rob Romanchuk, BHS, CIP, CCRC, CCRCP, vice chair of Schulman IRB.
“They’re twin sons of different mothers,” Romanchuk says. “They’re different in nature.” The U.S. Food and Drug Administration emphasizes that the intended use of drugs is achieved through chemical action or by being metabolized by the body. A device, on the other hand, is not dependent on being metabolized by the body to achieve any of its intended purposes.
For these and other reasons, the execution of device studies is different, Romanchuk says. “If research professionals don’t understand the distinction at its most fundamental levels, then it’s problematic,” he adds. However, professionals who become well versed in both can move back and forth between conducting device or drug studies.
Romanchuk has worked both sides of the street. He focused on research operations for more than a decade in terms of conducting and managing studies, and building the infrastructure for research. He also spent time as a professional on the human subjects protection side of the equation.
One of the biggest differences between device and drug trials is the issue of permanence. When a drug is not approved by regulatory authorities or otherwise is dropped from the clinical trials process, it is not usually that complex to discontinue its use in participants and turn off the lights on the study. However, if a device in clinical trials is disapproved or abandoned, the issue is complicated if it’s some kind of implant, Romanchuk points out.
Webinar: Meeting the Challenges of Device Studies. Join Romanchuk June 21 for this ACRP Webinar that will help you identify best practices to assure successful device studies, understand the differences between drug and device studies, and understand current trends and challenges related to device studies. View Program Details
Implications for a patient in a device trial are obviously different, Romanchuk notes: “That must be taken into account when you design a study, and when you inform and enroll subjects.”
There are other important differences to consider between device and drug trials. For example, there are usually far fewer participants in device trials, and there are no phases as such. Instead, the stages of research are divided into pilot studies to gauge effectiveness and optimize protocols, and pivotal studies for the intended populations.
Placebos are also problematic in device studies. “You don’t use that word in device studies,” Romanchuk notes. What you’ll hear is about device investigators conducting “sham procedures.” In such cases, the study usually involves performing the procedure without implanting or activating the device, so that from the perspective of the patient, is it not possible to tell which arm s/he is in, Romanchuck explains.
Shams are usually single-blind, not double-blind, situations. “As you can imagine, a sham is impossible to pull off for the operator,” and that’s one of the reasons it’s not commonly used, Romanchuk says. However, it remains the closest you can get to a “placebo” in a device study.
A more common “placebo” equivalent is to implant the device in all subjects, but activate it for those in only one arm of the study. Then after treatment period one, either cross all subjects over to the other arm or make them all active for treatment period two. “Or you can tack on an ‘open-label’ extension [to the study], in which all subjects get active treatment,” Romanchuk says.
Doing this makes the “risk/benefit” discussion with potential participants in advance of a study much more straightforward, since all subjects stand to benefit at one point, according to Romanchuck. “If a sham or inactive arm is included in a study that requires a surgical procedure to implant a device, it’s hard to justify the risk with no benefit,” he adds.
Author: Michael Causey
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