Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data.

Gerardus J Hassing,Michiel J van Esdonk,Gerard J P van Westen,Adam F Cohen,Jacobus Burggraaf,Pim Gal

British journal of clinical pharmacology（2022）

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摘要

Our analysis showed that effect sizes <2× the between-measurement SD of the investigated outcome frequently go unnoticed by blinded reviewers, indicating that the weight given to these blinded analyses in current phase I practice is inappropriate and should be re-evaluated.

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关键词

clinical trials,drug development,pharmacodynamics,phase I

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