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Product: Darbepoetin alpha (Cranes)
Protocol Number: 20190404
Date: 28 June 2022Page 1 of 45Summary Table of Study Protocol
Titles of Erythropoietin Stimulating Agents (SAS) in
Patients Receiving
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What is a phase 3 randomized?
A phase 3 randomized is a type of clinical trial that tests the effectiveness and safety of a new treatment or drug in a large group of participants, comparing it to a standard treatment or placebo.
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Sponsors of clinical trials, including pharmaceutical companies, biotech firms, and academic institutions, are required to file a phase 3 randomized trial with regulatory authorities.
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To fill out a phase 3 randomized, one must complete the trial protocol, register it with a clinical trial registry, and submit all required documentation to the relevant regulatory body, including informed consent forms and safety monitoring plans.
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The purpose of a phase 3 randomized trial is to confirm the effectiveness of a treatment in a large population, monitor side effects, compare it with standard or placebo treatments, and gather information that will allow the treatment's use in clinical practice.
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Information that must be reported includes trial design, participant demographics, interventions, outcomes, adverse effects, statistical analysis plans, and trial results.
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