Final answer:
Therapeutic Confirmatory Studies are predominantly Phase III clinical trials designed to confirm a drug's efficacy and safety on a larger scale. Common designs include randomized-sequenced double-blind, placebo-controlled crossover clinical studies and randomized, open-label, crossover studies.
Step-by-step explanation:
Examples of 'Therapeutic Confirmatory Studies' typically relate to the later stages of clinical trials for new drugs or treatments. These are the studies conducted after initial safety and efficacy of the drug has been established, commonly referred to as Phase III trials. They aim to confirm the therapeutic efficacy and safety in a larger patient population, often across multiple centers globally. Such studies are designed to provide a clear answer to whether a drug should be approved for general medical use. Two common design approaches for these studies are the randomized-sequenced double-blind, placebo-controlled crossover clinical study and the randomized, open-label, crossover study. The former is where patients receive either the drug or a placebo in a random order in two different periods, without knowing which one they are receiving. The later allows both the researcher and the participant to know which treatment is being administered and allows for comparison between two drugs, or between a drug and a placebo.