Randomized controlled trial« Back to Glossary Index
A randomized controlled trial (RCT) refers to clinical trial design in which the participants are assigned by chance to separate groups to evaluate the therapy being studied. The study also includes a control group, which is undergoing the same rigors of the study with placebo or standard clinical therapy. In most cases, RCT trials are also double-blind.
Double-blind RCTs are considered the Gold Standard to determine the safety and efficacy of a therapy. However, this study design may not always be possible in therapies being developed for a rare or genetic disease due to the limited number of participants meeting the eligibility criteria. This type of study may also not be considered ethical in conditions the progress quickly.
Patient-Centered Outcomes Research Institute: Glossary