Scale Development for Clinical Assessment

Abstract

Critical elements of all clinical investigations are the parameters and clinical scales employed for the assessment of relevant parameters. Their suitability to correctly reflect tactile or visual findings about skin condition collected by experienced investigators as morphological parameters or as overall clinical diagnoses determine the relevance and effectiveness of an investigation. Hence, when first beginning to design a clinical investigation into skin physiology/morphology and their pathologic variants, the foremost relevant question is whether the parameters to describe endpoints or surrogate endpoints of the effect are covered by existing clinical grading scales for proper, valid documentation of changes. These scales must be suitable to generate data addressing the study objectives, i.e., they have to be adequately sensitive. If they are close to, but not fully in line with the respective needs, the obvious question is whether they can be adjusted to meet the needs or whether they have to be replaced by new grading scales to be developed by the investigator, often in close cooperation with the study sponsor, using the same, similar, or new parameters for assessment of changes in skin physiology/morphology