BREAKFAST, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
8:45AM-9:45AM
ISSUE PANELS – SESSION III
Clinical Outcomes Research Issues
8:45AM-9:45AM
IP9: OBSERVATIONAL RESEARCH: ARE WE OBSERVING IMPROVEMENT? Moderator: Jeffrey Trotter MM, Executive Vice President, Phase IV Development Group, PharmaNet, Deerfield, IL, USA Panelists: Rhonda Bohn MPH, ScD, FISPE, Principal, Rhonda L. Bohn, LLC, Waban, MA, USA; Louise Short MD, MSc, Medical Leader - Health Plan Market, Healthways, Inc., Franklin, TN, USA; Joanna Haas MD, MSc, Vice President, Global Patient Safety and Risk Management, Genzyme Corporation, Cambridge, MA, USA
Health Policy Development Using Outcomes Research Issues
8:45AM-9:45AM
IP10: DO MECHANISTIC MODELS GENERATE "NOVEL INSIGHTS" BEYOND WHAT CAN BE EXTRACTED FROM EMPIRICAL MODELS? Moderator: Marc-david Cohen PhD, Chief Science Officer, Archimedes Inc., San Francisco, CA, USA Panelists: Mark S. Roberts MD, MPP, Professor of Medicine, Health Policy and Management, Industrial Engineering and Clinical and Translational Science and Chief, Section of Decision Sciences and Clinical Systems Modeling, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Somesh Nigam PhD, Vice President, Office of Evidence Based Medicine, Medical Devices & Diagnostics, Johnson & Johnson, New Brunswick, NJ, USA; Julia Aledort Gaebler PhD, Director, Health Economics & Outcomes Research, Amylin Pharmaceuticals Inc., San Diego, CA, USA
8:45AM-9:45AM
IP11: COMPARATIVE EFFECTIVENESS IN THE US: DOES THE EUROPEAN EXPERIENCE SHED ANY LIGHT ON HOW IT SHOULD BE APPLIED? Moderator: Ted Sweeney MA, CFA, Partner, PriceSpective LLC, Blue Bell, PA, USA Panelists: Naomi Aronson PhD, Executive Director, Technology Evaluation Center, Blue Cross Blue Shield Association, Chicago, IL, USA; Nina Owcharenko, Deputy Director, Center for Health Policy Studies, Heritage Foundation, Washington, DC, USA; Keiron Sparrowhawk MBA, MSc, Partner, PriceSpective LLC, London, UK
PATIENT-REPORTED OUTCOMES RESEARCH ISSUES
8:45AM-9:45AM
IP12: VALUE OF PATIENT PARTICIPATION IN HEALTH ECONOMICS Moderator: Durhane Wong-Rieger PhD, MA, President & CEO, Institute for Optimizing Health Outcomes, Toronto, ON, Canada Panelists: Michael Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK; Devidas Menon PhD, MHA, Professor, Health Policy & Management, University of Alberta, Edmonton, AB, Canada; Larry Lynd PhD, Associate Professor, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada
9:45AM-10:00AM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
10:00AM-11:30AM
THIRD PLENARY SESSION
BAYESIAN AND ADAPTIVE TRIAL METHODS MEETS THE PRAGMATIC CLINICAL TRIAL AND COMPARATIVE EFFECTIVENESS RESEARCH
Although comparative effectiveness research (CER) can be informed by synthesis of existing clinical information and analysis of observational data, randomized clinical trials (RCTs) are often needed to address real world evidence questions. However, traditionally designed RCTs are ill suited to address real world issues. Bayesian and adaptive approaches incorporate existing pivotal trials, systematic reviews, models, observational studies into the trial design and change [or "adapt"] in response to information generated during the trial allowing for focusing on subpopulations who respond differentially. This session will provide a critical overview of these techniques and discuss the opportunities and challenges in the evolving CER environment.
10:00 – 10:20 AM
Moderator/Speaker: Bryan R. Luce PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation, Bethesda, MD, USA
10:20 – 10:40 AM
Speaker: Steve Slovick MBA, Partner/President, PriceSpective LLC, Blue Bell, PA, USA
10:40 – 11:00AM
Speaker: Keaven M. AndersonPhD, Executive Director, Clinical Biostatistics and Research Decision Sciences, Merck Research Laboratories, North Wales, PA, USA
11:00 – 11:15AM
Speaker: Laurie B. Burke RPh, MPH, Director, Study Endpoint and Label Development, Center for Drug Evaluation and Research Food & Drug Administration, Silver Spring, MD, USA (invited)
11:15 – 11:30AM
DISCUSSION
11:30AM-11:45AM
ISPOR 15th Annual International Meeting Research Presentation Awards
11:45AM-12:45PM
POSTER AUTHOR DISCUSSION HOUR – SESSION III
12:45PM-1:45PM
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
W30: ENRICHING BUDGET IMPACT MODELS FOR US PAYERS WITH RELEVANT CLINICAL OUTCOMES Discussion Leaders: Ipek Özer-Stillman MS, Director, Abt Bio-Pharma Solutions, Lexington, MA, USA; Jeffrey D. Miller MS, Senior Director, Abt Bio-Pharma Solutions, Inc., Lexington, MA, USA; Bjorn Bolinder MBA, Head, Primary Care, Global Health Outcomes, Merck & Co., Kenilworth, NJ, USA; Mason W. Russell MAPE, Vice President, Abt Bio-Pharma Solutions, Inc., Lexington, MA, USA
Health Care Policy Development Using Outcomes Research
1:45PM-2:45PM
W31: OPTIMIZING STRATEGIC DIRECTION WITH SYSTEMATIC VALUE DEVELOPMENT Discussion Leaders: Karen A. Joy, Director, Health Economics and Outcomes Research, IMS Health, Falls Church, VA, USA; Sonya J. Lewis RPh, MBA, Pharmacy Director, BCBS of Colorado/Nevada, Lafayette, CO, USA
Patient-Reported Outcomes/PREFERENCE-BASED Research
1:45PM-2:45PM
W6: DEFINING A RESPONDER: IMPLEMENTING THE PATIENT-REPORTED OUTCOME (PRO) GUIDANCE RECOMMENDATIONS Discussion Leaders: Lori McLeod PhD, Head, Psychometrics, Patient-Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA; Ron D. Hays PhD, Professor of Medicine, Division of General Internal Medicine and Health Services Research, University of California at Los Angeles, Los Angeles, CA, USA; Susan Martin MSPH, Senior Director, Patient-Reported Outcomes, RTI Health Solutions, Ann Arbor, MI, USA; Sheri Fehnel PhD, Vice President, Patient-Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA
W33: THE GROWTH OF SOCIAL NETWORKS AND OPPORTUNITIES FOR OUTCOMES RESEARCH Discussion Leaders: Elisa Cascade MBA, Vice President, iGuard, Falls Church, VA, USA; Eric Gemmen MA, Senior Director, Quintiles, Falls Church, VA, USA; Stephen Doogan, Head of Business Development, WeAre.Us, San Francisco, CA, USA; Murtuza Bharmal PhD, MS, Director, Quintiles, Falls Church, VA, USA
2:45PM-3:00PM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
3:00PM-4:00PM
WORKSHOPS – SESSION VI
Clinical Outcomes Research Issues
3:00PM-4:00PM
W34: THE USE OF OBSERVATIONAL EVIDENCE FOR COMPARATIVE EFFECTIVENESS RESEARCH: IS IT FIT-FOR-PURPOSE? Discussion Leaders: Rachael Fleurence PhD, Senior Research Scientist, Center for Health Economics and Science Policy, United BioSource Corporation, Bethesda, MD, USA; Kyle Fahrbach PhD, Senior Biostatistician, United BioSource Corporation, Lexington, MA, USA; David Vanness PhD, Assistant Professor, Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
3:00PM-4:00PM
W35: IMPROVING THE PREDICTION OF MEDICAL RISK AND BENEFIT Discussion Leaders: Patricia Cerrito DrPH, Professor, University of Louisville, Louisville, KY, USA; John Cerrito PharmD, Clinical Pharmacist, Kroger Pharmacy, Louisville, KY, USA
W38: IMPUTING HEALTH EXPENDITURE DATA ONTO EMR DATABASES: PROS AND CONS OF PROPENSITY MATCHING AND REGRESSION BASED TECHNIQUES Discussion Leaders: John Rizzo PhD, Professor, Department of Economics, Stony Brook University, Stony Brook, NY, USA; Candace Gunnarsson EdD, President, S2 Statistical Solutions Inc, Cincinnati, OH, USA; Teresa Zyczynski PharmD, MBA, MPH, Research & Analytics Leader, GE Healthcare, Princeton, NJ, USA; Amy Ryan MS, Researcher, GE Healthcare Clinical Data Services, Princeton, NJ, USA
