“FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted… to ensure the analysis wasn’t cherry-picked.”
MD
Meryl Dersarkissian
FDA Watch ·
Daniel McCarville · The Audit Podcast · Ep 297: Benford's Law w/ Daniel McCarville
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Recommend using at least ~80 observations when applying statistical Benford tests (D statistic, MAD score, chi-square)
≈80 rows
“FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted… to ensure the analysis wasn’t cherry-picked.”
“What we tried to do is, you know, using large language models and AI, we tried to really ground probability of success in an empiric data set, where we use Bayesian statistics.”
“We actually have a feature that we're testing… uses AI to score your profile and make recommendations… you need to show more sides of yourself.”
“Once I did really high sampling and I saw that curves were smooth, it kind of clicked… use a statistical model for this to be more efficient”
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