Q&A with Patrick McCabe, Sr. Clinical Project Manager at genae Americas
Q: Is there anything in the design of a cardiovascular trial that you foresee as a source of difficulty when it comes to executing
A: When designing a trial, it can be easy to forget the human factors component. Sure, the device may be designed to specification and will function as designed, but how simple is the device to use or implant? Similarly, is the procedure or data collection process complicated?
Let’s say that your study involves utilizing both your device and comparator at the same time. On paper, the stepwise timing of study measurements may make complete sense, but to the operator, the defined order could lead to complications or delays in making those measurements. It is important to design a study with the Investigators and their staff in mind. Fine tuning of inclusion/exclusion criteria is also critical.
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?
• Are there procedures specific to the conduct of a cardiovascular trial that sponsors/principal investigators should be aware of?
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