Monotherapy comparative trials: equivalence and differences in clinical trials.

@article{Chadwick2001MonotherapyCT,
  title={Monotherapy comparative trials: equivalence and differences in clinical trials.},
  author={D. W. Chadwick},
  journal={Epilepsy research},
  year={2001},
  volume={45 1-3},
  pages={101-3; discussion 105-7}
}
Investigators are familiar with the concept of clinical trial design to detect differences. Equivalence studies set out to define how similar treatments might be. They become important for two reasons: (1) similarities may be as clinically important as differences and (2) in therapeutic areas with drugs of proven efficacy already marketed, it may be ethically difficult to perform placebo-control studies. If equivalence is rigorously defined (the minimal clinically important difference), they… CONTINUE READING