Study at a Glance: Old Wine in a New Bottle

• Activity Number: 522
• Type: Contributed
• Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): William Coar*+
• Keywords: Statistical Graphics ; DMC ; IDMC ; DSMB

Abstract

Data Monitoring Committees (DMCs) are now standard for many types of clinical studies, and have primary roles of protecting patient safety and monitoring quality of study conduct. This is done through interim assessment of data throughout the course of a clinical trial. Recent trends suggest more concise reports be provided to the DMC allowing them to make well informed decisions. Of the numerous approaches that have been suggested, our focus is on better utilizing figures in a DMC report. Data coordinating centers have been incorporating presentation quality graphics in DMC reports for many years. This presentation re-emphasizes graphical approaches to supplement standard tables and listings. Graphics can allow easy assessment in many areas of interest to DMCs such as enrollment, distribution of baseline characteristics, adverse events of interest, laboratory parameters over time, as well as some measure of treatment benefit. Graphics can also be used to assess patient follow-up and quality of data. Examples of incorporating graphics to quickly assess interim data will be presented from an oncology setting. Merits for and against this approach will also be addressed.