|
Abstract:
|
Use of statistics in drug development has been traditionally dominated by tables, listings and textual summaries. Although documentation of numerical results is necessary in a regulated industry like biopharmaceuticals, there is an increasing appreciation of graphics in the communication of the same results from a study. Graphical displays can succinctly yet eloquently drive home a message that lengthy tabular summaries are hard-pressed to do. This is true for studies in late phase, as well as, early clinical development, such as sequential dose-finding studies, where decisions on escalation and de-escalation usually involve multiple stakeholders with varying backgrounds. Graphical displays are especially important when quick and forceful arguments are required to be made in a relatively limited time as part of a compact presentation to a large and often heterogeneous audience, as is often the case in presentations made to health authorities. This presentation will describe the successful use of simple graphical outputs in responding to health authority questions from a late-phase registration study, as well as, touch upon the use of graphics in early phase dose-finding studies.
|
