Section outline

  • Collapse all Expand all

  • Thursday, January 7 2016; 3:00 PM - 5:00 PM

    Lecture:  Class Logistics; Introduction History of Pharmacoepidemiology

    • History of pharmacoepidemiology
    • Different types of questions
    • Who’s asking/answering the questions: academia, government and industry

    Faculty:  Michael Kelsh, D. Lilienfeld

    Location:  Mission Hall 2106

    • Prospectus:

    • EPI 262 Course Overview File

    • Session Slides:

    • Lecture 1 Intro and Class Logistics - Kelsh File

    • Required Reading:

      “What is Pharmacoepidemiology?” Strom BL., in Textbook in Pharmacoepidemiology pp. 3-16.

      "Views for Academia, Industry, Regulatory Agencies and the Legal System”  in Textbook in Pharmacoepidemiology pp. 63-98

    • Platt et al. The US FDA Mini-Sentinel Program-status and direction. PDS 21-S1-1-8, 2012 File
      Not available unless: Your ID number contains 02
    • Robb et al. The US FDA Sentinel Initiative-Expanding the horizons of medical product safety. PDS 21-S2-9-11, 2012 File
      Not available unless: Your ID number contains 02

  • Thursday, January 14, 2016; 3:00 PM - 5:00 PM

    Lecture:  Study Design in Pharmacoepidemiology

    • Basic epidemiologic study designs used in pharmacoepidemiology
    •   - Comparative advantages/disadvantages
    • Epidemiology measures of effect
    • Study Bias and methods to address bias
    • Case Studies

    Faculty:  Michael Kelsh

    Location:  Mission Hall 2107

    • Session Slides:

    • Lecture2 Basic Design and Analysis - Kelsh File

    • Required Reading:

      “Study designs available for Pharmacoepidemiologic Studies”  in Textbook of Pharmacoepidemiology  pp. 30-39

      Rothman KJ  Six Persistent Research Misconceptions; J Gen Intern Med DOI: 10.1007/s11606-013-2755  2014

       

    • Avorn J. In Defense of Pharmacoepidemiology – Embracing the Yin and the Yang of Drug Research. NEJM-357-2219-2221, 2007 File
      Not available unless: Your ID number contains 02
    • Jick H, Garcia Rodriguez LA, Perez-Gutthan S. Principles of epidemiological research on adverse and beneficial drug effects. The Lancet - 352(9142)-1767-70, 1998 File
      Not available unless: Your ID number contains 02
    • Schneeweiss S. Developments in post-marketing comparative effectiveness research. Clinical Pharmacol Therapeutics -82(2)-143-156, 2007 File
      Not available unless: Your ID number contains 02
    • Maclure M, Fireman B, Nelson JC et al. When should case-only designs be used for safety monitoring of medical products. Pharmacoepidemiol Drug Saf. 21(S1)- 50–61, 2012 File
      Not available unless: Your ID number contains 02
    • Strom 2006 Study Designs for Pharamacoepidemiologic Research File
      Not available unless: Your ID number contains 02

  • Thursday, January 21, 2016; 3:00 PM - 5:00 PM

    Lecture:  Pharmacoepidemiology: Data Sources

    • Data needs in pharmacoepidemiology
    • "Real World Data" - what is the hype?
    • Data sources:
      • Administrative claims data
      • EMRs
      • Other (e.g. registries, existing cohorts, surveys)
    • Practical aspects in working with databases
    • Limitations/strenghts of each type of database
    • Examples

    Faculty:  Deborah Kim

    Location:  Mission Hall 2107

    • Session Slides:

    • Lecture 3 - Databases for pharmacoepidemiology File

    • Required Reading:

      “Sources of Pharmacoepidemiology Data” in Textbook of Pharmacoepidemiology pp 99-177, 190-202

    • Jick SS, Kaye JA, Vasilakis-Scaramozza C, et al., Validity of the General Practice Research Database. Pharmacotherapy. 23(5)-686-9, 2003 File
      Not available unless: Your ID number contains 02
    • Warren JL, Klabunde CN, Schrag D, et al., Overview of the SEER-Medicare Data. Content, Research Applications, and Generalizability to the United States Elderly Population. Medical Care. 40 (8 Supplement) IV-3-IV-18, 2002 File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • Suissa 2008 - Immortal time bias in pharmacoepi File
      Not available unless: Your ID number contains 02
    • Levesque 2010 Immortal Time Bias File
      Not available unless: Your ID number contains 02

  • Thursday, January 28, 2016; 3:00 PM - 5:00 PM

    Lecture:  Pharmacoepidemiology and Drug Safety

    • Drug safety monitoring (pharamacovigilance) - review of regulatory data systems:
      • FAERS/Spontaneous Reports
      • FDA Sentinel
      • Clinical trial safety data
    • Safety signals - evaluation across pre-clinical to post-market settings
    • Definitions
    • International Perspective (EMA - PASS studies)
    • Case Study - Vioxx and cardiovascular disease

    Faculty:  Michael Sprafka

    Location:  Mission Hall 2107

    • Session Slides:

    • Lecture 4 Sprafka Pharmacovigilance and Regulatory Considerations File
    • Hammad TA, Neyarapally GA, Iyasu S, Staffa JA, Dal Pan G. The Future of Population-Based Postmarket Drug Risk Assessment. A Regulators Perspective. Clin Pharmacol Ther. 94-3-349-5, 2013 File
      Not available unless: Your ID number contains 02
    • Schneeweiss S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiology and Drug Safety. 19-858–868, 2010 File
      Not available unless: Your ID number contains 02
    • Ray A. Beyond debacle and debate. developing solutions in drug safety. Nat Rev Drug Discov. 8-775-9, 2009 File
      Not available unless: Your ID number contains 02

  • Thursday, February 4, 2016; 3:00 PM - 5:00 PM

    Lecture:  Advanced Methods/Analytical Approaches

    • Goal - to provide "exposure" and familiarity with more complex analytical tools
    • Review of confounding by indication
    • Methods to address confounding by indication:
      • Propensity Score analyses
      • Instrumental variables
      • Marginal Structural models
    • Changing exposure over time
    • Validity studies

    Faculty:  Fei Xue

    Location:  Mission Hall 2107

  • Thursday, February 11, 2016; 3:00 PM - 5:00 PM

    Lecture:  Advanced Methods/Quantitative Bias Analyses, Meta Analysis

    Quantitative Bias Analyses:

    • When is bias analysis practical and productive?
    • How to identify/select the biases that should be addressed?
    • Selecting a method to model biases
    • Assigning values to the parameters of a bias model
    • Interpretation of bias analysis results 

    Meta-Analysis

    • Review of evidence-based medicine: Mission and methods
    • Meta-Analysis
    • How to conduct, when is it appropriate to combine results across studies?
    • Analytical approaches - e.g. "fixed effects", "random effects"
    • Strengths and limitations
    • Case Studies

    Faculty: Fiona Callaghan/Michael Kelsh

    Location:  Mission Hall 1406

    • Session Slides:

    • Lecture 6 PV MetaAnalysis Feb 11 2016 File
    • Lecture 6 Quantitative Bias Analysis Feb 11 2016 File

    • Required Reading:

      Roundtable discussion of Vioxx/Avandia and other safety studies

    • Lash Fink 2003 Quantitative Biase Assessment Epi File
      Not available unless: Your ID number contains 02
    • Lash et al 2014 Good Practices in Quantitative Bias Assessment Int. J. Epidemiol File
      Not available unless: Your ID number contains 02
    • Guyatt et al., Users’ Guides to the Medical Literature XXV. Evidence-Based Medicine. Principles for Applying the Users’ Guides to Patient Care. JAMA 284(10)-1290-1296, 2000 File
      Not available unless: Your ID number contains 02
    • Concato et al., Randomized, Controlled Trials, Observational Studies, and the Hierarchy Of Research Designs. N Engl J Med 342(25) 1887-92, 2000 File
      Not available unless: Your ID number contains 02
    • Juni et al., Risk of cardiovascular events and rofecoxib. cumulative meta-analysis. Lancet 364(9450) 2021-2029, 2004 File
      Not available unless: Your ID number contains 02
    • Poole 2007 Coffee and Myocardial Infarction. File
      Not available unless: Your ID number contains 02

    • Assignment:

  • Thursday, February 18, 2016; 3:00 PM - 5:00 PM

    Lecture: Benefit-Risk Analyses/Safety Data Systems

    Faculty:  M. Smith/Meir Pinco

    Location:  Mission Hall 2107

  • Thursday, February 25 2016; 3:00 PM - 5:00 PM

    Lecture:  Health Economics

    • Economic evaluation in Health Care: overview of basic definitions and concepts
    • Uniqueness of health care in the context of economic evaluation
    • Cost Benefits/Cost Effectiveness Analyses
    • Health Technology Assessment

    Faculty:   Michael Woolley

    Location:  Mission Hall 2107

    • Session Slides:

    • Pharmacoeconomics 20160225 File

    • Required Reading:

    • Meltzer 2001 - Health Economics for Physicians File
      Not available unless: Your ID number contains 02
    • Mark 2001 Circulation- Medical Economics Cardiovascular Medicine Part 1 File
      Not available unless: Your ID number contains 02
    • Mark 2002 Circulation-2002 Medical Economics Cardiovascular Medicine - Part 2 File
      Not available unless: Your ID number contains 02
    • Arrow, K. Uncertainty and the Welfare Economics of Medical Care. American Economic Review, December 53(5), 941-973, 1963 File
      Not available unless: Your ID number contains 02
    • Cutler DM. The lifetime costs and benefits of medical technology. J Health Econ. Dec 1;26(6) 1081-100. Epub, 2007 File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • Horton Ethics Lancet 1997 File
      Not available unless: Your ID number contains 02

  • Thursday, March 3, 2016; 3:00 PM - 5:00 PM

    Lecture:  Medical Devices, Pharmacoepidemiology and Regulatory Processes

    • Efficiency and Equity (in Economics)
    • Market and non-market solutions
    • The role of economic evaluation
    • Health Technology Assessment
    • Quality of Life Measurement in Pharmacoepidemiology and Health Economics studies

    Faculty:  D. Cher

    Location:  Mission Hall 2107

    • Session Slides:

    • Medical Devices Approvals File

    • Required Reading:

      “Use of quality of life measurements in Pharmacoepidemiology” in Textbook of Pharmacoepidemiology  pp. 291-299.

      Weinstein, MC (1990). Principles of Cost-Effective Resource Allocation in Health Care Organizations. International Journal of Technology Assessment in Health Care, 6, pp 93-103. doi:10.1017/S0266462300008953.

    • Ross JS et al 2015 FDA and Cardiovascular Medicine File
      Not available unless: Your ID number contains 02
    • Kumar 2015 Cardiovascular Device Safety Surveillance (post market) File
      Not available unless: Your ID number contains 02
    • Jarow JP 2015 US Medical Device Regulation File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • Assignment: Optional narrative description

  • Thursday, March 10, 2016; 3:00 PM - 5:00 PM

    Lecture:  Ethics in Pharmacoepidemiologic Research Class Summary

    • Ethical Issues:
      • Equipoise
      • Authorship
      • Conflicts of Interest
    • Conflicts of interest
      • Is financial/funding the only source? - discussion of financial, social politiacal/idealogical, and professional conflicts
      • Approaches on how to deal with conflicts of interest

    Faculty:  Michael Kelsh/Alex Liede

    Location:  Mission Hall 2107

    • Session Slides:

    • Perspectives in Ethics 10Mar2016 File

    • Required Reading:

    • Acquavella et al re ASCO author Policy PDS 2014 File
      Not available unless: Your ID number contains 02
    • DeAngelis CD, Fontanarosa PB, Flanagin A. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA 286-89-91, 2001 File
      Not available unless: Your ID number contains 02
    • Rothman KJ. Conflict of interest. The new McCarthyism in science. JAMA 269-2782-84, 1993 File
      Not available unless: Your ID number contains 02
    • Greenland S. Commentary- Addressing corporate influence through ethical guidelines. Int J Epidemiol 37-57-59, 2008 File
      Not available unless: Your ID number contains 02
    • Pearce N. Corporate influences on epidemiology. Int J Epidemiol 37-46-53, 2008 File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • Assignment: Optional narrative description