Table 1 Background – PATIENT-REPORTED OUTCOMES 'PRO' SYMPOSIUM CONCEPTUAL AND METHODOLOGICAL ISSUES – International Society for Pharmacoeconomics and Outcomes Research

Data to evaluate the efficacy or effectiveness of treatment can come from a variety of sources, including laboratory tests, clinician evaluation, and the patients themselves. In the outcomes research community, the term "patient-reported outcomes (PRO)" is used to refer to a host of outcomes that can be provided only by the patient. Examples of these outcomes include symptom severity, perception of daily functioning, feelings of well being, global impressions of the impact of treatment on daily life, satisfaction with treatment, and health-related quality of life. The role that PROs can and should play in evaluating the efficacy of pharmaceuticals and medical devices and the means by which these outcomes are communicated to clinicians and consumers are subjects of much discussion and debate.

Over the past 2 years, representatives from ERIQA¹, ISOQOL², ISPOR³, and PhRMA HOC⁴ (now collectively called the Patient-Reported Outcomes (PRO) Harmonization Group) have been participating in discussions with the FDA about the use of health-related quality of life (HRQL) and, more recently, patient reported outcomes (PRO) in pharmaceutical research and communications. An overview of PRO Harmonization Group initiatives, meetings, presentations are at the PRO Harmonization Group website at http://www.pro-harmonization-group.com This symposium will highlight activities of the PRO Harmonization Group, and provide an overview of discussions related to conceptual and methodological issues with specific examples.

1. European Regulatory Issues on Quality of Life Assessment (ERIQA) Group

2. International Society for Quality of Life Research (ISOQOL),

3. International Society for Pharmacoeconomics and Outcomes Research (ISPOR),

4. Health Outcomes Committee of PhRMA (PhRMA HOC).