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Heather Kopetski
Blog Post

FDA Guidance on Non-Inferiority Clinical Trials to Establish Effectiveness

In November 2016, the FDA released final guidance  on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.

Blog Post

An Interactive Suite of Data Visualizations for Safety Monitoring

This is the fourth in a series of posts introducing open source tools Rho is developing and sharing online. To improve safety monitoring, we created a suite of interactive data monitoring tools we call the Safety Explorer. Safety Explorer can be configured to include a variety of charts specific to each study.