So your site would like to try a device trial?
So your site would like to try a device trial?
Consider this expert advice on device studies
Clinical trial investigators and directors who would like to begin handling device trials probably could find contracts if they first did their homework, several experts say.
"Number one, you need all of the infrastructure in place before even beginning to market your site," says Kathi Durdon, MA, CCRP, clinical operations associate with Welch Allyn Inc., a device company based in Skaneateles Falls, NY. Welch Allyn was founded by a physician and optometrist in 1910. Durdon spoke about how to market your research site at the Society of Clinical Research Associates (SoCRA) device workshop, held May 19-21. 2009, in Chicago.
"Sites a lot of times will jump the gun and have uncertified, new coordinators," Durdon says. "They are interested, but don't have all their ducks in a row, and that's not a good way to start."
That approach will mean it'll take longer to get into device studies, and it won't reflect well on them in the end, she adds.
Durdon and other experts offer these suggestions for how best to market your site for device trials:
• Build up your potential, starting with staff training: "We train our staff to know who our customer is and why we're doing this," says Patricia Larrabee, RN, NP, chief executive officer of Rochester Clinical Research Inc. of Rochester, NY.
It's a given that clinical trial sites should have investigators and research coordinators certified in human subjects research protection, Durdon says.
"We also like to see that investigators have invested in coordinators, allowing them to attend workshops and maybe have sites promote education at a facility," she says.
Sponsors like to see that sites train staff in good clinical practice, as well, Durdon says.
"From a sponsor's point of view, they like to see that the site has made that investment," she adds.
Also, it's extremely important to have standard operating procedures (SOPs) in place, Durdon says.
"We ask if they have SOPs in place," Durdon says.
For instance, the site should have SOPs on informed consent, contracting and budgeting, case report forms, data entry, IRB submission, and clinical trial investigation file management, she adds.
"That tells us whether the site is experienced," Durdon says.
Rochester Clinical Research has SOPs and has standardized its practices, Larrabee says.
"That's key to making sure you meet the goals necessary to getting the job done well, she says. "We've standardized our tools and have a standard form for collecting information about adverse events."
The AE form is color-coded, making it easy to review, and it's kept up to date, Larrabee says.
"Putting procedures in place is critical to collecting good data, which is a goal for all of us," she adds.
A vision statement also is a good place to start.
"We have a vision statement and remember what our customer needs and what needs to be done," Larrabee says. "Then you allocate resources to meet that goal."
For example, Rochester Clinical Research has two dedicated recruiters, Larrabee says.
Sometimes device companies will want a site to provide staff and some functions, but not conduct the entire clinical trial, she notes.
"We like working with new companies and mixing it up — it keeps it interesting for the staff," Larrabee says. "We hope to do research, but it's still an income stream, and it's relationship-building."
About 95% of the time Rochester Clinical Research will do all of the clinical trial work for a study, but there's no reason to be limited in one's vision and refuse to work with the minority of sponsors who want to contract for a piece of the work, Larrabee adds.
• Showcase your abilities: "I saw one company in Europe where I really liked the way they showcased their capabilities on their Web site," says Deborah Schenberger, PhD, a research analyst for Nerac based in Tolland, CT. Schenberger spoke at the 5th Annual Orthopaedic Manufacturing and Technology Conference 2009 in Rosemont, IL, June 24-25, on domestic and international medical device reimbursement/regulatory changes.
"You could go to their Web site and navigate it to see physically what types of clinical trials you could do with them and what the capabilities were of their researchers," Schenberger says. "You could get a pretty clear idea of what you'd receive by the end of a trial."
Many Web sites lack the details that make them attractive marketing tools for clinical research sites, Schenberger notes.
"They're like the title page of an article and don't have details," she explains. "So you have to call them, and most people will just move on."
Sponsors and clinical research organizations (CROs) will want to get some solid information off a CR site's Web site before calling the site, so they can make a preliminary evaluation of whether or not this would be a good match, Schenberger says.
It's difficult for CR sites to market themselves to device companies, partly because there aren't as many device companies as there are pharmaceutical companies, Larrabee says.
"You should keep your eyes out for professional society meetings, where you're more likely to hear what's going on down the pipeline," she suggests.
And independent CR sites might particularly look for device studies that involve an outpatient setting, such as exercise biofeedback devices, she adds.
• Network whenever possible: Larrabee networked at a clinical trial conference, meeting Durdon and convincing her to give Rochester Clinical Research a chance.
"We love Rochester Clinical Research," Durdon says. "I was speaking at a conference in San Diego and met Pat Larrabee, and we talked about her facility."
As a result of that networking encounter, Welch Allyn conducted a site visit at Rochester Clinical Research and has since been using the CT site for recruitment and other research work, Durdon says.
"They have a large database; they have the University of Rochester, a multitude of experience," Durdon explains. "It's easy for us to go there, and they make it simple for us."
Another useful strategy is for CR directors to attend device workshops and to search for the newest biofirm press releases to find potential new trials, Larrabee suggests.
"You could subscribe to a subscription service that sends you updates on what's coming," she adds.
• Prepare for site visit: When Welch Allyn first visited Rochester Clinical Research, the device company was impressed with how the site had specific monitoring office space, Durdon says.
"It's wonderful — the monitor has a facility to go to," she says. "The files are there; the patients are there, and it's adjacent to a patient care area, and we like to see that the research patient care area is separate from the standard of care area in a practice."
While this type of dedicated space often isn't feasible at smaller practice areas or larger academic areas, a research site that has it will stand out in a sponsor's mind, Durdon adds.
Also, it's very important that CT sites have device storage areas.
"The device must be stored and accessible only to people conducting research and only used on people who have been enrolled in the project and who have met eligibility criteria," Durdon says. "Having a locked, safe storage space is premium."
For some device trials, a site's lack of suitable space for device storage can become an insurmountable restriction, she adds.
Clinical trial investigators and directors who would like to begin handling device trials probably could find contracts if they first did their homework, several experts say.Subscribe Now for Access
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