ABSTRACT
The purpose of graphics or visualization tools for benefit–risk (B–R) assessment and presentation of medicinal products is to illuminate effects and aid decision making among different stakeholders including the patients, clinicians, sponsors, regulatory agencies, and payers. Thoughtful and creative utilization of graphical displays in B–R assessment could often help deliver safe and effective interventions to the patients and enhance the development process. In this chapter, a thorough review of graphical presentations that have appeared in the medical and statistical literature, including peer-review journals, special interest group publications, scientific reports, and Food and Drug 198Administration advisory committee meeting materials, is presented. On the basis of the review and with a focus on application to the clinical trial setting, new perspectives and guidance for the application of graphics are presented. Refinements to existing graphics are provided along with illustrative examples to give readers proper context for the appropriate use of various graphics in practice.
