“We'd say, control F on steroids and matching words… I would build scripts to find those matching words and flag them”
NC
Nick Coleman
Lawyerist Podcast ·
Meryl Dersarkissian · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
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Use external control arms drawn from real-world sources that match trial eligibility and endpoint definitions
“We'd say, control F on steroids and matching words… I would build scripts to find those matching words and flag them”
“Our multimillion dollar multi-year investment in scientific human trials, peer reviewed, placebo controlled and randomized”
“Companies must have internal controls verified by an internal team, external auditors validate them, and an independent board committee receives the reports.”
“I want to basically, with Airbnb, I am, you know, trying to use AI to bring people together in the real world.”
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