Q&A with Patrick McCabe, Sr. Clinical Project Manager at genae Americas
Q: How do you go about ensuring that a site is appropriate for a cardiovascular study?
A: There are so many great Cardiovascular clinical research sites out there, but not all of them will be a great fit for every study. genae has partnered with device sponsors on over 300 cardiovascular studies, encompassing 660 sites worldwide, of which 160 are in the US. Some sites and Investigators prefer to participate in large, multi-institutional phase 3 or 4 studies, while others may prefer to be one of a few investigators working on a FIH study.
Once you lock in on the type of site/Investigator that would be a good fit for the study, you need to dig a little deeper. Ask how many ongoing studies they have. Ask how many staff, or research nurses or study coordinators, will be part of the study. Check the CVs of the staff to see if they have sufficient experience in the type of device or patient group that you are targeting. It’s critically important research staff, any research staff, can effectively communicate study specifics to potential subjects. Otherwise, patients may be more reluctant to participate.
Other topics to consider are how effective a site’s contracts team is at turning around the contract or whether they will be utilizing a central IRB or local IRB. Central IRBs meet more frequently and I’ve never heard of them not having quorum to review and approve or respond to a submission. Plus, addition of sites to a protocol, once approved of course, is easier than undertaking full reviews for each and every local IRB.
Discover our other Q&A videos:
• Are there any specific pieces of information you would include in a site feasibility survey for a cardiovascular trial?
• Are there any barriers to sites getting approved in a cardiovascular trial?
• For cardiovascular studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
• What unique aspects of a cardiovascular subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a cardiovascular trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a cardiovascular trial that you foresee as a source of difficulty when it comes to executing?
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