Section outline

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  • Thursday, January 8, 2015; 3:00 PM - 5:00 PM

    Lecture:  Class Logistics; Introduction to Pharmacoepidemiology

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

    Faculty:  Michael Kelsh

    Location:  Mission Hall 1407

    • Prospectus:

    • UCSF Pharmacoepidemiology Syllabus 12 December 2014 File

    • Session Slides:

    • Lecture 1 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 15, 2015; 3:00 PM - 5:00 PM

    Lecture:  Pharmacoepidemiology in Drug Development/Study Design

    • Experimental and Observational Studies
    • Descriptive Epidemiology – Estimating patient populations, characterizing natural history of disease
    • Defining the exposure, outcomes and covariates
    • Selecting the appropriate study design
    • Sources of systematic error
      • Selection Bias
      • Confounding
      • Misclassification

     

    Faculty:  Michael Kelsh

    Location:  Mission Hall 1407

    • Session Slides:

    • Lecture 2 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

  • Thursday, January 22, 2015; 3:00 PM - 5:00 PM

    Lecture:  Pharmacoepidemiology: data sources

    • Types and description of different data sources
    • Database purpose, strengths and limitations
    • Using databases to answer different types of research questions (surveillance/drug utilization; studies of intended / unintended effects; treatment prediction)

    Faculty:  Vicky Chia

    Location:  Mission Hall 1407

    • Session Slides:

    • Lecture 3 File
    • Lecture3a - Immortal Time Bias - Further Comments 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
    • 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 29, 2015; 3:00 PM - 5:00 PM

    Lecture:  Pharmacoepidemiology and Drug Safety, Data Systems

    • — The Rules Governing Medicinal Products
    • —  Data Mining and Signal Detection in Spontaneous Reporting Systems
    • —  Drug Development in the Post Vioxx Era - A Paradigm Shift in Pharmacovigilance

    Faculty:  M. Sprafka/Mier Pinco

    Location:  Mission Hall 1407

    • Session Slides:

    • Lecture4 Clinical Development Information Systems - Pinco File
    • UCSF Lecture V2 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 5, 2015; 3:00 PM - 5:00 PM

    Lecture:  Advanced Methods and Analytical Tools - Examples of Application to Pharmacoepidemiology

    • Advanced Analytical Tools
      • Instrumental variables
      • Structural models
      • Propensity methods

    Faculty:  F Xue

    Location:  Mission Hall 1407

    • Session Slides:

    • Advanced Methods for PharmacoEpidemiology 2 File

    • Required Reading:

      “Advanced Approaches to Controlling Confounding in Pharmaco-epidemiologic Studies”  in Textbook of Pharmacoepidemiology pp 324-336

      Brookhart MA, Rasen JA, Schneeweiss S, Instrumental variable methods in comparative safety and effectiveness research.  Pharmacoepi and Drug Safety 2010; 19: 537-554

      Schneeweiss S, Rassen JA, Glynn RJ et al., High dimensional propensity score adjustment in study of treatment effects using health claims data.  Epidemiol 2009; 20:512-522

  • Thursday, February 12, 2015; 3:00 PM - 5:00 PM

    Lecture:  Evidence Based Medicine, Meta-Analysis, Case Studies

    Evidence-based medicine: the state of the art

    • Understand the genesis of evidence based medicine
    • Understand the use and application of ‘meta-analyses’ and ‘systematic reviews’ in the generation of evidence based medicine
    • Explore the value of meta analysis in regulatory decision making: the Vioxx example
    • Case Study:  Effect Measure Selection in MetaAnalysis – A Case study from Pharmacoepidemiology

    Faculty:  Michael Kelsh/ F. Callaghan

    Location:  Mission Hall 1407

    • Session Slides:

    • PV sample size power File
    • PV MetaAnalysis File
    • Lecture5b - Meta-Analysis Case Studies V2 File

    • Required Reading:

      Roundtable discussion of Vioxx/Avandia and other safety studies

    • 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:

      Student Presentations

    • New RAS-Mutant Pancreatic Adenocarcinoma With Combined BRAF and MEK Inhibition for Metastatic Melanoma File
      Not available unless: Your ID number contains 02
    • Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes File
      Not available unless: Your ID number contains 02
    • Inhibition of Mutated, Activated BRAF in Metastatic Melanoma File
      Not available unless: Your ID number contains 02
    • Caterson et al. - 2012 - Maintained intentional weight loss reduces cardiov File
      Not available unless: Your ID number contains 02
    • James et al. - 2010 - Effect of Sibutramine on Cardiovascular Outcomes i File
      Not available unless: Your ID number contains 02
    • Vemurafenib in patients with BRAFV600 mutated metastatic melanoma: an open-label, multicentre, safety study File
      Not available unless: Your ID number contains 02
    • RECORD RosiglitazoneRosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial File
      Not available unless: Your ID number contains 02
    • Progression of RAS-Mutant Leukemia during RAF Inhibitor Treatment File
      Not available unless: Your ID number contains 02

  • Thursday, February 19, 2015; 3:00 PM - 5:00 PM

    Case Studies - Student presentations

    Faculty:  Michael Kelsh

    Location:  Mission Hall 1407

  • Thursday, February 26, 2015; 3:00 PM - 5:00 PM

    Lecture:  Economics and Economic Evaluation in Health Care

    • 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:  M. Woolley

    Location:  Mission Hall 1407

    • Session Slides:

    • Pharmacoeconomics for UCSF 20150226 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.

    • 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

  • Thursday, March 5, 2015; 3:00 PM - 5:00 PM

    Lecture:  Ethics in Pharmacoepidemiologic Research

    • Sources of bias
    • Conflict of interest
    • Importance of equipoise
    • Publication issues

    Faculty:   A. Liede

    Location:  Mission Hall 1407

    • Session Slides:

    • Epi 262 - Lecture 9 - Perspectives in Ethics Alex Liede 2015 File

    • Required Reading:

    • 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
    • Rothman KJ. Conflict of interest. The new McCarthyism in science. JAMA 269-2782-84, 1993 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
    • 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
    • Acquavella et al re ASCO author Policy PDS 2014 File
      Not available unless: Your ID number contains 02

    • Optional Reading:

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

    • Assignment:

    • Egan 2014 Pancreatic Safety and Increetic Drugs File
      Not available unless: Your ID number contains 02
    • Postmarket Drug Safety Information Valdecoxib File
      Not available unless: Your ID number contains 02
    • Singh 2013 Pancreatitis Therapy and Diabetes File
      Not available unless: Your ID number contains 02
    • Advisory NSAID Use Antman 2007 File
      Not available unless: Your ID number contains 02
    • Arthritis Prevalence US Lawrence 2008 File
      Not available unless: Your ID number contains 02
    • Gale 2013 GLP-1 and Pancreatitis File
      Not available unless: Your ID number contains 02

  • Thursday, March 12, 2015; 3:00 PM - 5:00 PM

    Case Studies - Student Presentations

    Faculty:  Michael Kelsh

    Location:  Mission Hall 1407