Randomized Controlled Trial (RCT)

The terms “clinical study” or “clinically tested” are often used but seldom practiced. A clinical trial is designed and performed to serve a single function, to demonstrate the safety and efficacy of a device and product. There are numerous levels of trials that are used under specific circumstances, but the only acceptable trial that can support the sale of a therapeutic strategy is a level 1 or Randomized Controlled Trial (RCT).

Any trial short of a level 1 can only predict trends under the unique circumstances taking place at the time of the trial. There is not a definitive way to determine whether the device or procedure being analyzed is responsible for the observed clinical outcome. An equally valid theory for the clinical result could be based on environmental influences or a placebo effect. Grade B trials are necessary to determine whether a level 1 RCT is warranted.