Who actually decides whether a drug works?
In this episode, you’ll learn how biostatisticians play a critical role in clinical trials and FDA regulatory decisions. We break down how biostatisticians support Phase I–IV clinical trials, shape study design, determine sample sizes, analyze trial data, and influence regulatory approval.
You’ll also learn what happens on both sides of the table—where industry biostatisticians defend their analyses and FDA biostatisticians evaluate the evidence—plus the key difference between statistical significance and clinical significance.
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