Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: For valve studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
A: With valve studies, depending if it is surgical or delivery access approach, will have surgical risk factors that can affect the operative mortality or serious irreversible morbidity risk that are considered exclusions in the study protocol.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a valve study?
• Are there any specific pieces of information you would include in a site feasibility survey for a valve trial?
• Are there any barriers to sites getting approved in a valve trial?
• What unique aspects of a valve subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a valve trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a valve trial that you foresee as a source of difficulty when it comes to executing?
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