Device company expert discusses what sponsor needs to hear from PIs
Here are a few short tips
If your clinical trial site wants to expand to medical device studies, it would be a good idea to first listen to what a medical device sponsor wants.
Kathi Durdon, MA, CCRP, clinical operations associate with Welch Allyn Inc., a device company based in Skaneateles Falls, NY, offers these tips to sites:
• Show interest: "The first key thing is for a site to have interest in device research," Durdon says.
"We want to see that research interest and research understanding that are key to our developing our project," Durdon says.
• Be open to small studies: "For the most part, device trials are small numbers of enrollment," Durdon says.
"We don't have the phase III trials with thousands of participants," she adds. "We may have 100 participants, which is very large for a device trial."
• Work with very ill populations: Device trials often recruit from populations of critically-ill patients, Durdon says.
"This is so we can label the product as meeting rigorous testing requirements," Durdon says. "We may have a population of very sick children, and we're very careful in how qualify sites."
Also, the sponsor might pay a site extra to have at least two study coordinators working on the study, she adds.
• Bring on nursing PIs: "We have nurses who are our principal investigators," Durdon says. "We love to do research with nurses."
Nurses might promote device products that are easy to use, good for patients, and good for the hospital environment, she notes.
"That champion is the person who will help us get in the door and get the product tested," Durdon adds.
• Advocate research: "We like to see an environment where all the way down to even patient's relations people that employees know how important research is and they're advocates of research," Durdon says. "We like to know they're informing their patients that research is a viable option for them and that they're using research as part of their patient care when it should be part of their treatment options."
If your clinical trial site wants to expand to medical device studies, it would be a good idea to first listen to what a medical device sponsor wants.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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