(Many of these presentations are available to members in the Members Only area in PowerPoint format.)
7:30 a.m.-3:00 p.m.	Registration - Alumni Hall
8:00-8:15 a.m.	Welcome & Goals for the Symposium Suzanne L. West, PhD, MPH, Conference Organizer Elizabeth Andrews, PhD, MPH, ISPE President Jon C. Clouse, RPh, MS, ISPOR President-Elect
8:15-8:30 a.m.	Keynote Presentation - William L. Roper, MD, MPH Health care data and health: from numbers to outcomes Health care systems use data to document performance, improve accountability to the populations served, provide a scientific basis for best practices recommendations, and contribute to higher quality and greater efficiency of care. The translation of research into practice occurs when the producers, consumers, and sponsors of data forge durable collaborative relationships that transcend traditional distinctions between public and private, or academic and practitioner.
8:30-10:00 a.m.	Database Issues: Taxonomy, Development, Access Moderator: Deborah Shatin, PhD Organizational context and taxonomy of health care databases Organizational structure has implications for accessing and using health care databases for research purposes. Additionally, variables such as benefit coverage and health care delivery system implementation affect researchers' ability to answer specific epidemiologic questions. Richard Platt, MD, MSc Performing multi-center database research in a network of HMOs. Using the experience of the HMO Research Network, the policies and procedures that facilitate multi-center pharmacoepidemiology and other database research will be presented. Louise Wood, BSc(Hons), PhD Rosalind Coulson, PhC (Sydney), MSc, FRPharmS Revitalising the GPRD: plans, challenges and issues The General Practice Research Database (GPRD), its relationship with other parts of the Medicines Control Agency, the design and implementation of a new GPRD, and access issues to this research tool. Nancy A. Dreyer, MPH, PhD Brokering research for the pharmaceutical industry The process by which research questions are formulated, the role of an outside scientific contractor, and finding the appropriate partner for data. Also comments on data access, analysis, interpretation, and reporting. Questions & Answers
10.00-10:30 a.m.	Refreshment Break
10:30-12:00 noon	Database Issues: Strengths and Limitations Moderator: Suzanne L. West, PhD, MPH Brian L. Strom, MD, MPH Data validity issues in using claims data Use of claims data generates major issues of data validity which differ from studies using data collected de novo. A review some of these issues drawing on examples from both published and more recently unpublished data and general conclusions. Alexander M. Walker, MD, DrPH Pattern recognition in claims data Disease and health states typically produce recognizable sequences of claims, but they seldom result in single defining events. Pattern recognition for claims series must rest in the first instance on clinical insight into the natural history of disease. A machine-human partnership may enrich the claims-based "vocabulary" of disease, and may lead eventually to semi-automated evaluations of population health. Catherine A. Melfi, PhD Using databases for studying/comparing healthcare costs and resource utilization The advantages and pitfalls associated with conducting cost and resource utilization analysis using databases. Participants will gain an understanding of how to critically evaluate such studies. Panel Discussion
12:00 -1:00 p.m.	Lunch (Included in registration)
1:00-1:05 p.m.	Introduction to Afternoon Session Abraham G. Hartzema, PharmD, MSPH, PhD
1:05-2:15 p.m.	Uses of Databases: Evaluating Drug and Vaccine Safety & Recommending Policy Moderator: Harry Guess, MD, PhD Frank DeStefano, MD, MPH The Vaccine Safety Datalink Project The Vaccine Safety Datalink (VSD) is a collaborative project between CDC's National Immunization Program and several large health maintenance organizations that began in 1991 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. It has proven to be a valuable resource that has provided important information on a number of vaccine safety issues. Evelyn Rodriquez, MD, MPH CDER's evaluation of benefit-risk of marketed drugs. How FDA uses data from spontaneous reports, drug utilization and administrative databases to allow continuous benefit-risk evaluation of marketed drugs. Susan Ellenberg, PhD Vaccine safety studies: large randomized trials vs. database studies The rationale for sample sizes, extent of testing prior to licensure, and a discussion of post-marketing studies. Panel Discussion
2:15-2:45 p.m.	Break
2:45-4:00 p.m.	Uses of Databases: Economic Research and Formulary Recommendations Moderator: Jon C. Clouse, RPh, MS Frank Sloan, PhD Using secondary data for formulary evaluation How secondary data have been used in cost vs. benefit studies of drug use. Examples will be provided using Medicaid claims files and managed care data. Patricia Cowper, PhD Using databases to assess episodes of care for economic evaluation. There is no theory that pre-specifies the time horizon for clinical trials. However, time horizon is a critical parameter for economic evaluation of new therapeutic modalities. The strengths/limitations of administrative data to assess periods of illness for clinical trail design. John E. Paul, PhD NICE, fourth hurdle reviews, and database applications The experience of Glaxo Wellcome in making their first submission to the National Institute for Clinical Effectiveness (NICE) in the UK, and the use of databases in the new area of 'fourth hurdle' reviews and approvals. Keith Beard, BSc, MB, ChB, FRCP Systems for Medicines Evaluation in the UK Information on evolving systems in the UK for the evaluation of new and established medicines. These include the National Institute for Clinical Excellence (NICE) in England & Wales, the Scottish Health Technology Assessment Centre (SHTAC), and local Glasgow procedures. Reference will also be made to clinical guidelines, notably the Scottish Intercollegiate Guidelines Network (SIGN). Questions & Answers
4:00-4:45 p.m.	Database Issues on the Horizon Moderator: Trish Byrns, MD William Braithwaite, MD, PhD Update on Health Insurance Portability and Accountability Act (HIPAA) regulations HIPAA regulations were issued noting that privacy protections must be balanced with the public responsibility to support such national priorities as protecting public health, conducting medical research, and improving the quality of care. Comments and reactions to the Health and Human Services proposals will be presented. Judith K. Jones, MD, PhD Incorporting Genomics into Pharmacoepidemiology: The Promises and Pitfalls of Specimen Databases The horizons of pharmacoepidemiology will be changing as genomics moves to center stage. Opportunities for genetic definitions of populations lie within the growing array of serum and tissue banks that may greater further understanding of the variability in populations and help target prevention, treatment and risk factors. With these opportunities go many critical ethical and privacy issues that herald a need for careful deliberation. Lynn Bosco, MD, MPH Databases for Outcomes Research: What Has 10 Years of Experience Taught Us? The successes and failures of databases used for outcomes research. Examples will be taken from the Patient Outcomes Research Teams (PORTs), the Outcomes of Pharmaceutical Therapy program and other Agency for Healthcare Research and Quality (AHRQ) projects
4:45-5:00 p.m.	Conference Summary & Final Comments Hugh H. Tilson, MD, DrPH