Q&A with Rebecca Hinton, Clinical Project & Safety Manager at genae Americas
Q: Are there any barriers to sites getting approved in a neurology trial?
A: This is a conversation that starts with the study sponsor. Understanding what is important for the study, so that we can deliver sites that meet or exceed expectations. For example, some sponsors insist that Neurologists are board certified, and will not accept a site with less. Others are ok relaxing this criterion so long as the Neurologist has adequate experience.
Some Neurology studies have heavy administrative burdens that require the site staff to complete many neurological or outcome questionnaires with the patients. In this case having a research naïve staff could very well be a hinderance to successful study completion.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a neurology study?
• Are there any specific pieces of information you would include in a site feasibility survey for a neurology trial?
• For neurology studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
• What unique aspects of a neurology subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a neurology trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a neurology trial that you foresee as a source of difficulty when it comes to executing?
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