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by jpdus
975 days ago
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For P1 (which is only to prove safety) this may be the case, but for pivotal studies in P2 and later, participants are almost always randomized so cherry picking shouldn't be possible. But sure, the study design and primary/secondary endpoints are always levers to increase likelihood of admission. There are often long discussions with the FDA and other regulators on how the endpoints and study population should look like. |
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