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Appropriate and reliable data required for conclusive FIH/Phase 1 trials

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Clinical trials are intended to find answers to a research question by generating data to prove or disprove a hypothesis.

Clinical trials are intended to find answers to a research question by generating data to prove or disprove a hypothesis. First-in-Human (FIH) and most Phase 1 trials by their very nature are exploratory, without a statistical hypothesis. They are aimed at obtaining reliable information on the safety, tolerability, pharmacokinetics and mechanism of action of a drug.

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