Q&A with Patrick McCabe, Sr. Clinical Project Manager at genae Americas
Q: Are there any specific pieces of information you would include in a site feasibility survey for a cardiovascular trial?
A: It is important to understand how many ongoing studies they have and the study names. If a site is working on another study for a similar indication, you are competing for that patient pool. You should also determine what studies have been completed. This can give you an idea of the staff’s experience in recruiting this patient population and working with similar devices. If they have completed prior studies, ask how their site-specific enrollment was for those studies and who was the PI.
The reasons I bring this last one up is you might be working with a Co-Investigator from a previous study and find out that this individual was just a name on a delegation log. It’s important to know what role investigators play in what studies. Frequently, research nurses and study coordinators are shared across multiple investigators and studies. So, you will want to know planned staffing for your study and what the experience level for those staff members is. Not everyone is a strong communicator and potential subjects really need to understand what they can expect. Obviously, it is important that the site has access to the desired patient population with the targeted cardiovascular disease.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a cardiovascular study?
• 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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