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A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH OR 5/3/05ERLOTINIB IN PATIENTS WITH SMALL CELL LUNG CANCER AND 13 BRAIN METASTASESWhat is a research
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A phase III trial is a randomized controlled study involving a large group of participants to validate the effectiveness and safety of a new medication or treatment.
Pharmaceutical companies or sponsors who are conducting the trial are required to file a phase III trial.
To fill out a phase III trial, the sponsor must provide detailed information about the study design, participant criteria, research objectives, methodology, and safety monitoring procedures.
The purpose of a phase III trial is to confirm the findings of earlier phase trials, evaluate the clinical effectiveness of the treatment, and gather more data on safety and side effects.
Information that must be reported on a phase III trial includes study protocols, informed consent documents, data collection procedures, adverse event reporting, and statistical analysis plans.
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