Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: What unique aspects of a valve subject population make enrollment/recruitment/retention particularly difficult?
A: For valve studies, the innovative nature of the valve clinical trial makes it someone less difficult for the subjects to decide for this route; however, the fact that porcine or bovine valves do not require lifetime use of anticoagulant treatment might have the patients reconsider participating in a clinical trial.
Some of the patients involved in clinical trials have co-morbidities that can affect their willingness or ability to continue with the required follow-up; however, I have seen that the patients see such a great change in their quality of life that they do return to their follow-ups.
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?
• For valve 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 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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