For neurology studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
Are there any barriers to sites getting approved in a neurology trial?
Well-established client relationships, streamlined clinical operations, and dedicated, knowledgeable study teams drive the success of Medical Device Clinical Research. At genae, we view clinical research involving neurological and neurovascular disorders as a key focus area.
Are there procedures specific to the conduct of a neurology trial that sponsors/principal investigators should be aware of?
How do you go about ensuring that a site is appropriate for a neurology study?
What unique aspects of a neurology subject population make enrollment/recruitment/retention particularly difficult?
The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases.
Is there anything in the design of a neurology trial that you foresee as a source of difficulty when it comes to executing?
Are there any specific pieces of information you would include in a site feasibility survey for a neurology trial?
Most members of the FDA’s Medical Devices Advisory Committee panel on neurological devices said age should not be a consideration for inclusion in a clinical trial, but life expectancy should, and patients with less than one year of life expectancy should be excluded from studies.