Randomized clinical trials are widely accepted as the gold standard approach to test new line of drugs, therapies, or treatments. They reduce bias by randomly allocating patients to either a treatment or a control group. In this scenario, variables other than the planned medical intervention remain constant between the two groups. This way any observed differences can be attributed to the treatment being tested. However, outcome switching is one of the fallacies of these clinical studies and impacts the regulatory approval decisions.

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