 This webinar will review the recent article in Pain by Cooper et al that summarizes the findings of a meeting convened by IMMPACT, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. The article looked at key considerations and best practices governing design of acute pain studies. A single-dose analgesic study is usually the first step in a clinical development plan to establish the safety and efficacy for an acute pain medication. This first study should be conducted in an established postsurgical model to determine proof of concept, the effective dose range, analgesic properties such as time to onset of analgesic activity, magnitude of analgesic activity, and duration of analgesic effect. The relationship between dose and efficacy/safety also can be defined. Inclusion of a placebo arm allows for determination of the treatment effect and relative safety versus an untreated population. A positive control arm provides validation of the model, and relative potency against an established analgesic medication also can be determined
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