Regardless of the approach being studied, all proposed research projects must compare at least two active alternatives. If the applicant proposes usual care as a rational and important comparator in the proposed study, then it must be described in detail, coherent as a clinical alternative, and properly justified as a legitimate comparator (e.g., usual care is guidelines-based). The choice of usual care must represent current clinical and ethical standards of care. It must also be accompanied by an explanation of how the care given in the usual care group will be measured in each patient and how appropriate inferences will be drawn from its inclusion. Usual care must be described as mentioned above to ensure that it accounts for geographic and temporal variations and that it has wide interpretability, applicability, and reproducibility.
Have more questions? Submit a request