Are there procedures specific to the conduct of a cardiovascular trial that sponsors/principal investigators should be aware of?

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

Q: Are there procedures specific to the conduct of a cardiovascular trial that sponsors/principal investigators should be aware of?

A: ​​​​​​​One complication that you can run into during the contracting phase is defining what can and what cannot be considered standard of care at each site. This can vary hospital to hospital and country to country. You may be required to reimburse for certain procedures in one country but not another. For example, cardiac biomarkers for detection of a peri-procedural MI are not universal but can be critical to meeting the safety component of testing. These biomarkers could be key to identifying a non STEMI that might be missed with 12-lead ECG alone.

Discover our other Q&A videos:
•  How do you go about ensuring that a site is appropriate for a cardiovascular study?
•  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?
​​​​​​​•  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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