All types of trials can yield valuable scientific evidence when used appropriately to test various hypotheses or to observe various food or drug effects in humans. Each clinical trial type requires specific clinical trial methods and data analyses. Randomised Clinical Trials (RCTs) can be designed to test for “superiority” (one is better than the other), “non-inferiority” (one is not worse than the other) or “equivalence” (one cannot be differentiated from the other) among other study designs.
Randomised Human Clinical Trials (RCT's) are considered the gold standard of evidence for the scientific substantiation of claims by many regulatory bodies such as EFSA & FDA. RCT's add medical knowledge & provide effectiveness of interventions for disease prevention. However, optimal trial design does not always require a randomized, double-blind, placebo-controlled trial (many types of clinical trials can yield scientifically valid results). Our team understands the difference in clinical study design and we advise our sponsors on the most suitable type for their goal.