Hypothesis

The primary hypothesis is built on the primary endpoint and usually sets the sample size. Changing it after the data are seen undermines the result.

testable statement, derived from the objective (3.37) of the clinical investigation (3.8) to draw a conclusion about this objective, based on a pre-specified statistical test Note 1 to entry: The primary hypothesis is formulated based on the pre-defined primary endpoint (3.22) and is usually used to calculate the sample size.

ISO 14155:2020, clause 3.25