“INTEGRATION OF PATIENT PERSPECTIVES IN DRUG EVALUATIONS: HARMONIZATION, CONSENSUS AND DIVERGENCE”

Turning the Patient Voice into a Convincing Scientific Argument

Moderator & Speaker: Patrick Marquis MD, Conference Co-chair & Managing Director, MAPI Values, Lyon, France

Harmonizing Regulatory Requirements for Patient Reported Outcomes

ISPOR is one of four organizations (ISPOR, ISOQOL, PhRMA HOC and ERIQA) participating in discussions with drug regulatory authorities 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 the PRO Harmonization Initiative

Speaker: Jean Paul Gagnon PhD, Director of Public Policy, Aventis Pharmaceuticals, Bridgewater, NJ, USA

PRO Conceptual, Methodological, and Clinical Issues

Speaker: Ingela Wiklund PhD, MSc, Director, AstraZeneca Research & Development, Outcomes Research Department, Molndal, Sweden

Health-related Quality of Life and Patient Reported Outcomes – A French Regulatory Perspective

Speaker: Olivier Chassany MD, Hôpital Lariboisière, Paris, France

One of ISPOR's role as a scientific society is to assist in the development and dissemination of scientific policy (good practices in health outcomes research and its use in decision-making). Toward this goal, the ISPOR Health Science Committee consisting of six Task Forces was created,. The four Good Research Practices Task Forces are addressing methodological issues and/or developing 'toolboxes' for the outcomes researcher. The Code of Ethics Task Force is addressing ethical issues to consider when conducting any type of outcomes research study. The Use of PE/HE Research Information Task Force is to assure that good research practices of any study incorporate the needs and 'reality checks' of healthcare decision-makers as well as to develop a 'toolbox' for the healthcare decision-maker in interpreting and  using outcomes studies.

USE OF PHARMACOECONOMICS/HEALTH ECONOMIC INFORMATION IN HEALTHCARE DECISION-MAKING - COMMUNICATION & INTERPRETATION ISSUES
ISPOR Task Force On Use Of Pharmacoeconomic/Health Economic Information In Healthcare Decision-Making: Progress Report is located at: http://www.ispor.org/workpaper/healthscience/TFPEUse.pdf and will be the subject of this session.
Speaker: Michael Drummond PhD, Chair, ISPOR Health Science Task Force on Use of Pharmacoeconomics/Health Economic Information in Healthcare Decision-making and Director, University of York, Centre for Health Economics, York, UK

RETROSPECTIVE DATABASE STUDIES GOOD RESEARCH PRACTICES - METHODOLOGY ISSUES
ISPOR Task Force On Retrospective Databases-Checklist for Retrospective Database Studies: A DRAFT For Discussion is located at: http://www.ispor.org/workpaper/healthscience/TFRetrospective.pdf and will be the subject of this session.
Speaker: Brenda Motheral RPh, PhD, Chair, ISPOR Health Science Task Force on Good Research Practices - Retrospective Database Studies and Senior Director of Outcomes Research, Express Scripts Inc, Maryland Heights, Missouri, USA

OUTCOMES ASSESSMENT USING QUALITY OF LIFE INDICATORS GOOD PRACTICE STANDARDS - METHODOLOGY
The Measurement Of Quality Of Life In Clinical Trials: Considerations Of Good Research Practices: A Draft for Discussion is located at http://www.ispor.org/workpaper/healthscience/TFQoL.pdf and will be the subject of this session.
Speaker: Paul Kind Mphil, Chair, ISPOR Health Science Task on Good Research Practices - Quality of Life Studies and Senior Research Fellow, University of York, Centre for Health Economics, York, UK