Q&A with Patrick McCabe, Sr. Clinical Project Manager at genae Americas
Q: What unique aspects of a cardiovascular subject population make enrollment/recruitment/retention particularly difficult?
A: Cardiovascular disease is so prevalent that it is listed as the underlying cause of death for 1 in 3 deaths in the US. That makes sense though when you consider that cardiovascular disease encompasses coronary heart disease, stroke, heart failure, and high blood pressure, among others. The high prevalence of death can lead to some patients not willing to try experimental technologies. They would rather elect treatment via the current gold standard.
Another unique aspect of cardiovascular diseases that make this subject population difficult to work with can be time requirement to treatment. For example, an ischemic stroke patient should receive clot dissolving treatment or clot extraction within hours of having stroke. This can lead to a complicated consent processes as the patient themselves may have cognitive impairment. A well-defined set of inclusion/exclusion criteria is key to success in cardiovascular diseases but can also lead to a severe narrowing of patient population if too stringent.
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?
• 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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