Characterizing the Use of External Controls for Augmenting Randomized Control Arms and Confirming Benefit
Friends of Cancer Research worked together with Medidata to define the methodological processes and discussed the implementation and opportunities for formal regulatory use of external controls.
You will learn:
- Different approaches to constructing an external control along with the use of hybrid designs
- Hybrid designs that supplement/augment the control group in randomized control trials with data from an external population
- Statistical methodology to help address potential biases and improve the usefulness of the data that rely on patient summary data
- Scenarios where external controls can help guide the implementation within a clinical study
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