Before new medicines can be placed on the market, medicines’ developers have to generate and submit evidence to regulators that the benefits outweigh the risks of the new medicine in the targeted indication. A critical part of such evidence is the design of the pivotal clinical trial and the choice of endpoints. For regulators, a primary endpoint in a pivotal trial needs to be accurate, reliable, sensitive to change, reflect the objectives of the trial, and be relevant to patients and clinicians.

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