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CASE COMPREHENSIVE CANCER CENTER
___
STUDY NUMBER:CASE1414ClinicalTrials.gov NCT #:NCT02898259PROTOCOL DATE:April 11, 2022STUDY TITLE:A Phase IB/II Trial of Thalidomide (Realized), Ixazomib
and Rituximab
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What is phase iii study of?
Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or said to have the statistical power to expand the therapeutic indications of the study drug which means the drug is used as a therapy for one indication and is assessed as a potential treatment for other indications.
Who is required to file phase iii study of?
Phase III studies are typically filed by pharmaceutical companies or research institutions conducting the study.
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Phase III studies should be filled out in accordance with the study protocol and any regulatory requirements set forth by the governing bodies overseeing the study.
What is the purpose of phase iii study of?
The purpose of a Phase III study is to further evaluate the safety and efficacy of a drug or treatment in a larger patient population.
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Phase III study reports typically include details on the study design, patient population, results, statistical analysis, adverse events, and conclusions.
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