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Abstract:
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Many outcomes rely on a visual assessment by a physician. For example, aesthetic outcomes and the level of bleeding are often judgments and not strict measurements. To design a clinical trial where the primary outcome is a judgment, not a measurement, it is necessary to develop a visual assessment tool or scale. The purpose of the scale is to allow comparisons in the amount of improvement. The scale must be validated, demonstrating that evaluators can use the scale consistently and that the increments on the scale are meaningful. This talk will describe the process for how to develop these outcomes and how to present them to the FDA for use in future clinical trials.
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