Regulatory Guidelines and FDA's Perspective on the Collection and Analysis of the Radiographic Data in Rheumatoid Arthritis Clinical Trials

• Activity Number: 368
• Type: Topic Contributed
• Date/Time: Wednesday, August 11, 2004 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Boguang A. Zhen*+
• Companies: U.S. Food and Drug Administration
• Keywords: clinical trial ; regulatory guidance ; radiographic data ; missing data ; repeated measurements ; statistical method

Abstract

Rheumatoid arthritis (RA) is a chronic, symptomatic disease that can result in a variety of outcomes with different chronologies, severities, and overall patient effects. Over the past decade, there has been a search for better measures to describe patient outcomes in RA clinical trials. One of the important outcome variables for RA therapy is the structure damage as measured by x-ray. However, collection, analysis, and presentation of the radiographic data are challenging. One often needs to deal with issues such as repeated measurements over a long period of time, multiple radiographic readers, multiple co-primary endpoints, selection of analysis method, handling of missing radiographic data, presentation of data in labeling, etc. The author will introduce the regulatory guidance for clinical development programs seeking claim of inhibiting progression of structure damage for products used in RA treatment. The author will also present and discuss concerns raised during the review of submissions with radiographic data.