A concise display of multiple end points for benefit-risk assessment.
The assessment and representation of benefit-risk "balance" in pharmaceutical development have become increasingly important. Although the methodologies may vary considerably in complexity, most approaches to benefit-risk assessment require the simultaneous consideration of information pertaining to multiple end points for multiple treatments. However, the lengthy data tables and displays that are frequently used make this assessment difficult. Using an example from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study, this note presents a conceptually simple visualization that facilitates understanding of information on multiple points.
Department of Epidemiology, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Titusville, New Jersey, USA. blevitan@its.jnj.com
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D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003196:Computer Graphics; D003627:Data Interpretation, Statistical; D003658:Decision Making, Computer-Assisted; D023381:Endpoint Determination; D006801:Humans; D010352:Patient Dropouts / Q000706:statistics & numerical data; D010601:Pharmacology, Clinical / Q000379:methods* / Q000639:trends; D018570:Risk Assessment / Q000379:methods*; D012559:Schizophrenia / Q000188:drug therapy; D012984:Software; D013223:Statistics as Topic
D014150:Antipsychotic Agents