Shannon Keith Email and Phone Number

I have comprehensive experience working in the field of patient reported outcomes with a specific focus on clinical trial endpoint selection within the pharmaceutical industry. As a consultant in this industry, I've led multiple research projects across multiple medical conditions and age groups (including pediatrics), most aimed at either developing or validating instruments that are fit-for-purpose for use as an endpoint within a specific condition. My work generally involves leading literature reviews of both qualitative and quantitative literature, qualitative interview studies, gap analyses to determine whether there are any gaps in the literature pertaining to a particular instrument, developing conceptual models, writing reports and drafting dossiers, and preparation of FDA briefing books. More recently, I've also worked to support the use of patient reported outcomes in RWE (Real World Evidence). Most of the work I do is guided by the FDA Guidance for Patient Reported Outcomes.