Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: Are there procedures specific to the conduct of a valve trial that sponsors/principal investigators should be aware of?
A: It will really depend on the type of access, i.e. if it’s open heart, or with a delivery system. Sponsor need to ensure proper training of the investigators and all other study team responsible for collection of study data. A lot of times we see missing data that was not captured consistently due to a lack of understanding from the site regarding the requirements.
The sponsor might also be using a delivery system that is specific for this type of device. It is important that the site has a clear understanding of the delivery system to be used.
For these types of trials, a team of specialists need to ensure that each subject is carefully reviewed prior to enrollment in the study. All inclusion and exclusion criteria must be carefully assessed to ensure that the patient is a right candidate for the type of clinical device trial.
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?
• 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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