A licensed/registered individual trained to diagnose, treat, or dispense medication to a subject e.g., physicians, dentists, pharmacists or nurses.
Hypothesis-testing Studies
Also known as “confirmatory trials” as defined in the ICH Harmonised Tripartite Guideline E9. Statistical Principles for Clinical Trials. Stats Med 1999;18:1905-42. Whereas exploratory trials serve to set direction (i.e., to generate hypotheses) for future possible studies, “hypothesis-testing trials” serve to examine pre-stated questions (i.e., to test hypotheses) using statistically valid plans for data analysis and provide firm evidence of safety and/or efficacy to support product claims.
