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Abstract:
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Medical device approvals require a well-conducted pivotal study to gain FDA approval. There is a common misconception that these pivotal studies are unique and nonstandard. This talk will identify common statistical themes faced in the planning of pivotal device studies inclusive of study design options, historical data use, control group choices, endpoint multiplicity issues, offset choice for a noninferiority study, data pooling across strata and sites, sample-size calculation, prospective analysis plan requirements, population definitions for effectiveness and safety, and adverse events vs. complications. ICH and GCP linkage will be cited. Examples will be provided to depict agency precedents and sponsor objectives.
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