PURPOSE: This workshop will demonstrate the use of secondary analysis of qualitative data for the development of PRO instruments. The session will provide an overview of the technique and methodological underpinnings, its application to different types of data, and its use in the analysis of existing qualitative data for the development of new PRO instruments. More specific topics such as access to data and issues around ethical approval will also be discussed.  DESCRIPTION: The FDA recognizes the use of qualitative interviews with patients as an important step in the development of a new PRO instrument. Secondary analysis of qualitative interviews allows for an independent investigation of a new research question, different from the intentions pursued in the primary study. This is a useful technique which allows for the use of existing data whilst preserving valuable patient input. This session will be presented in 3 steps. The first section will cover the underpinnings of secondary analysis and its application, particularly for the development of PROs. The second section will involve the demonstration of secondary analysis on existing patient and clinician interviews to derive themes for a new PRO. At this stage, the audience will be invited to think of a new research question and, with the use secondary analysis techniques on interview transcripts, generate codes and themes to be used in the development of a new PRO. The final section will discuss the challenges faced by this approach as well as the more general benefits for development of PRO instruments. Audience participation in discussions will be encouraged throughout the session.