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Clinical Trials

3. Classification

Clinical trials can also be classified by whether the trial is:
  • The first to compare a specific treatment (exploratory); or
  • A further trial trying to confirm a previous observation (confirmatory) (Day, 1999).

An exploratory study might also seek to identify key issues rather than to confirm or challenge existing results regarding the treatment effect. For example, it might look at the impact of a new drug in a specific subset of patients who have additional diseases to the main disease of interest, such as diabetic patients with heart disease. On occasions, a study can have both confirmatory and exploratory aspects. For instance, in a confirmatory trial evaluating a specific treatment, the data can also be used to explore further hypotheses, i.e., subgroup effects that have to be confirmed by later research.

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Day S. (1999) Dictionary of clinical trials. Chichester: John Wiley & Sons.