Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: Is there anything in the design of a valve trial that you foresee as a source of difficulty when it comes to executing?
A: Device trial designs which compare very different types of procedures, are susceptible to imbalances in treatment adherence and follow-up because some participants may have a strong preference for one therapy and because blinding is not feasible.
Since incomplete treatment adherence could bias results toward a conclusion of noninferiority, analyses of both the intention-to-treat cohort and the cohort restricted to participants who received the assigned therapy (the as-treated cohort) have been important for these studies.
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?
• 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?
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