NBME 23 Phase 2 (NBME Answers)

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NBME 23 Answers

nbme23/Block 1/Question#5 (reveal difficulty score)
A study is conducted to examine the ...
Phase 2 🔍 / 📺 / 🌳 / 📖
tags: FA19p256 clinical_trials biostats

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submitted by ∗lfsuarez(160)

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Phase II studies test the efficacy of a drug. This second phase of testing can last from several months to two years, and involves up to several hundred affected patients.

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polyomavirus FA2019 p256. Does the drug SWIM (1. Safe 2. Work 3. Improve from standard 4. Market surveillance) +3

cherrypie key here is acknowledging that "100-200" patients is considered small/moderate, NOT "large". Large = stage 3 +1

drdoom More extensive discussion of clinical trials in this NBME 21 thread (so, heads-up SPOILERS ALERT) -> https://nbmeanswers.com/exam/nbme21/633#1782 +

drdoom Briefly, it’s not size of study that defines the phase (although that’s not a bad heuristic). Phases are determined by study goal: 1 - can I give this drug to normal humans, exclusive, without killing them? (“first, do no harm.”) 2 - can I give this drug to sick humans, exclusive, and provide ANY benefit whatsoever? (“for ppl with disease, does giving the drug do better than not giving anything at all?”) 3 - is it better than the current gold standard? (“does it do better than what’s already been approved?”) and, finally, 4 - did we miss anything that phase 1,2,3 didn’t catch? (“surveil the market for adverse effects that couldn’t be captured in phase 1,2,3”) +

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submitted by ∗usmile1(154)

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phase 2 = moderate number of patents with the disease of interest. Assesses treatment efficacy, optimal dosing, and adverse effects.

phase 3 = LARGE number of patients randomly assigned to either treatment group or the standers of care . Compares the new treatment to the current standard of care to see if there is any improvement.

FA19 p 256

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usmile1 standard* +1

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