How do the recent studies compare with the randomized controlled studies done by sanofi-aventis?
The studies published in Diabetologia used a disease registry, which are observational in nature. They did not require patient consent. The results are less rigorous than the gold standard of randomized controlled studies. Randomized controlled studies are designed to provide precise answers to specific medical questions. They require prior patient consent. These studies are used to evaluate the efficacy and safety of a drug. They evaluate the relative benefits and risks associated with the drug in a controlled environment.
