What is meant by meaningful results of controlled clinical trials?
The reference to meaningful results of controlled clinical trials in the PhRMA Principles is intended to refer to hypothesis-testing studies and to distinguish such trials from those that are merely exploratory in nature. Hypothesis-testing trials typically are the most rigorously conducted clinical studies and include all phase III studies, some earlier phase trials, and many studies of marketed products. Hypothesis-testing studies, by definition and design, always provide meaningful results.
