John F P Bridges, Ph.D. on PDUFA

For many, terms like patient-centered outcomes research and patient-focused drug development are new. For others, they are simply buzzwords that are aimed at putting a new spin on existing practices. As a researcher who has dedicated the majority of my career to the scientific study of the patients’ point of view, I rejoice in renewed interest in the patients’ perspective. The formal study of patient preferences emerged in the 1990s as a more scientific alternative to qualitative approaches to patient input. Using methods like conjoint analysis and discrete-choice experiments, this early literature challenged traditional approaches to outcomes research. This literature grew rapidly, aided by a greater acceptance of the theory and statistical methods used in choice experiments after Daniel McFadden was award the Nobel Prize in Economics in 2000 for his contribution to this field. Within the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), a working group was formed to advance the science of measure patient preferences in 2006. This group went on to develop the first consensus-based standards for the application of stated-preference methods in health, published in 2011, for the optimal experimental design of such experiments, published in 2013, and is currently working on a report detailing best practices for statistical analysis. While there was certainly a great deal of interest in studies that apply stated-preference methodologies, traditional ou...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news