Võrdlusravimiks

Võrdlusravimiks, often translated as comparator drug or reference product, is a term used in pharmaceutical and clinical research. It refers to an approved drug or placebo used in clinical trials to assess the efficacy and safety of a new investigational drug. The comparator drug serves as a benchmark against which the effects of the new treatment are measured.

The choice of comparator is critical and depends on several factors. If the new drug is intended to treat a condition for which existing treatments are available, an approved drug that is considered a standard of care is typically chosen as the comparator. This allows researchers to determine if the new drug is superior, non-inferior, or has a different benefit-risk profile compared to existing options. In cases where no established treatment exists, or to evaluate the inherent effect of the drug, a placebo might be used. A placebo is an inactive substance designed to look identical to the active drug being tested.

Using a comparator drug helps to establish the true therapeutic effect of the investigational agent. By comparing the outcomes in patients receiving the new drug to those receiving the comparator, researchers can isolate the specific benefits and side effects attributable to the new treatment. This rigorous comparison is a cornerstone of evidence-based medicine and essential for regulatory approval of new pharmaceuticals. The data generated from these comparative trials inform healthcare professionals and patients about the drug's place in therapy.