Online Program Home
My Program

Abstract Details

Activity Number: 323 - Graphics in Statistical Practice: Saying it with Pictures in the Classroom, Boardroom, or the Consulting Cube
Type: Invited
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistical Graphics
Abstract #326608
Title: Statistical Graphics in Drug Development: Dose-Finding to Dossier Submission
Author(s): Suddhasatta Acharyya*
Companies: Novartis pharmaceuticals corporation
Keywords: clinical-trials; dose-finding; health-authority; submission; late-phase; graphics

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.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2018 program