Making sure your study is successful: Formulating hypotheses correctly in a confirmatory trial
Virtually all late-stage trials—and certainly pivotal trials—are confirmatory in the sense that hypotheses are formulated in the protocol and tested using the data subsequently obtained in the trial. When designing a confirmatory clinical trial, hypotheses may often seem relatively obvious and, as a result, little effort is invested in them. However, a well-designed hypothesis can sometimes mean the difference between the success and failure of the study. It is, therefore, essential that when formulating trial hypotheses their implication for the study’s success be assessed.
Here are some common misconceptions about hypotheses:
In reality the hypothesis needs much foresight. So, what makes a well-designed hypothesis? A hypothesis that is…
The chance of success of a clinical trial is as good as the design of its hypothesis, so it is important to ensure that your study has a strong one.
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