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Confirmatory Efficacy Trial of a Traditional vs. Gamified Attention Bias Modification for Depression University of Texas at Austin, Dr. Christopher G. BeeversInitial NIH Grant Approval Date: July
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01
Develop a detailed protocol outlining the objective, design, methodology, and statistical analysis plan of the confirmatory efficacy trial.
02
Obtain approval from regulatory authorities and ethics committees before initiating the trial.
03
Recruit eligible participants who meet the specified criteria for inclusion in the trial.
04
Randomly assign participants to treatment and control groups to minimize bias and ensure validity of results.
05
Administer the investigational product or intervention according to the study protocol and monitor participants for any adverse events.
06
Collect and analyze data on the primary and secondary endpoints of the trial to assess the efficacy of the intervention.
07
Conduct statistical analyses to determine if the intervention has a significant effect on the outcomes of interest.
08
Report the results of the trial in a clear and transparent manner, following relevant guidelines and regulations.

Who needs confirmatory efficacy trial of?

01
Researchers investigating the effectiveness of a new drug or treatment.
02
Regulatory bodies requiring evidence of efficacy before approving a new intervention for use.
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Confirmatory efficacy trial is typically a phase III clinical trial designed to confirm the efficacy of a drug or treatment.
The pharmaceutical company or research organization conducting the trial is required to file the confirmatory efficacy trial.
The confirmatory efficacy trial is filled out by including data on study design, patient demographics, efficacy outcomes, adverse events, and statistical analysis.
The purpose of confirmatory efficacy trial is to provide additional evidence of the effectiveness of a drug or treatment, usually following positive results in earlier clinical trials.
Information reported on a confirmatory efficacy trial typically includes study protocol, statistical analysis plan, results, adverse events, and conclusions.
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