For cardiovascular studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?

Q&A with Patrick McCabe, Sr. Clinical Project Manager at genae Americas

Q: For cardiovascular studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?

A: ​​​​​​​In our experience, for Cardiovascular studies, site staff tends to overestimate the number of subjects they can recruit. The site selection process should emphasize appropriate estimation of the potential patient pool a site has to work with.

Of course, there are many possibilities that will lead to sites under recruiting for a given study. A few include competing studies or new technologies that an investigator may prefer for some reason. One pitfall that I have noticed as of late is insufficient coverage by coinvestigators for when a PI is on holiday, becomes ill, or is injured in some way.

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?
•  How do you go about ensuring that a site is appropriate for a cardiovascular study?
•  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?
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•  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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