Activity

  • Placebo-controlled trials are very important in establishing efficacy and statistical significance during the development of a medical device or drug. It should also be noted that a placebo doesn’t necessarily mean that no treatment is given to an individual in need of treatment. It simply means that where an investigational intervention may be provide within the structure of the standard of care, a placebo/blank is given. As an example, the Merck V710 Staphylococcus aureus vaccine underwent a phase 2B/3 clinical trial in which the vaccine was matched against a placebo control population. The study found that the vaccine actually was far more dangerous than the placebo in the population that developed postoperative S. aureus infections with a specific interleukin profile. As such, the trial was immediately halted and the vaccine was returned to the development pipeline. The placebo control was critical in establishing the efficacy, or in this example, the lack of efficacy of the vaccine. As such, placebo control is important in clinical research.