In laboratory research, investigators are expected to provide evidence that the conditions of the experiment, assumptions necessary to interpret outcomes, and other potentially influential factors will not bias the anticipated research outcomes and the investigators’ interpretations of these outcomes. Scientifically sound experiments and interpretations test for effects from independent variables and from the conditions and assumptions required to design and perform the experiments (36–39). These same stringent criteria must be applied for clinical research to realize laboratory levels of error controls. Experimental assumptions and conditions needed for testing or interpreting must be either compared to controls within the CT or empirically validated independent of the CT to claim that outcome effects or interpretive conclusions do not arise from the methods or assumptions.
