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News from the Florey Institute of Neuroscience and Mental HealthWORLDFIRST CLINICAL TRIAL COMMENCED IN ALCOHOL USE DISORDER PAGE 4SPRING 2019Brain Matters Spring 2019The Florey Institute of Neuroscience
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The world's first clinical trial refers to the initial studies conducted to evaluate the safety and efficacy of a new drug or treatment in human subjects.
Typically, sponsors of the clinical trial, which can include pharmaceutical companies or research institutions, are required to file for the world's first clinical trial.
To fill out the world's first clinical trial application, sponsors should include detailed information about the trial protocol, objectives, methodology, participant criteria, and safety data.
The purpose of the world's first clinical trial is to gather preliminary data on the safety and effectiveness of a new treatment or intervention before it can be further tested in larger populations.
Information that must be reported includes study design, participant demographics, informed consent process, drug dosage, anticipated outcomes, and adverse events.
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