Section outline

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    • Designing Clinical Research (Two Month)

      EPI 202 Summer 2018 (2 units).
      Course Director: Mark Pletcher, MD, MPH.
      Professor, Department of Epidemiology & Biostatistics

    • News forum
    • Christian Apfel Forum
      Not available unless: You belong to a group in Apfel Section
    • Ingrid Chen Forum
      Not available unless: You belong to a group in Chen Section
    • Cassie Kline Forum
      Not available unless: You belong to a group in Kline Section
    • Jason Flatt Forum
      Not available unless: You belong to a group in Flatt Section
    • Laura Jelliffe Forum
      Not available unless: You belong to a group in Jelliffe Section
    • Jennifer Smith Forum
      Not available unless: You belong to a group in Smith Section
    • Megie Okumura Forum
      Not available unless: You belong to a group in Okumura Section
    • Farzad Moazed Forum
      Not available unless: You belong to a group in Moazed Section
    • Joel Simon Forum
      Not available unless: You belong to a group in Simon Section
    • Jacqueline Torres Forum
      Not available unless: You belong to a group in Torres Section
    • Cooperberg Forum
      Not available unless: You belong to Cooperberg Section
    • Meyeon Park Forum
      Not available unless: You belong to a group in Park Section

  • Tuesday, July 31, 2018; 9:00 AM - 10:00 AM

    Lecture: Introduction to the Course, Clinical Research, and Research Questions

    Format: In-Class Lecture

    Topic: Introduction to the course; anatomy and physiology of research; components of a research protocol, and how measurements in a sample are used to draw inferences about a population; real-world tradeoffs between importance and feasibility

    Faculty:  Mark Pletcher

    Location: 

    MB-Genentech Hall 106, Byers Auditorium



  • Tuesday, July 31, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Tuesday, August 7, 2018; 9:00 AM - 10:00 AM

    Lecture: Subjects and Variables

    Format: In-Class Lecture

    Topic: Defining target and accessible populations; inclusion and exclusion criteria; balancing feasibility and generalizability; sampling; types of variables and measurements; maximizing precision and accuracy; example from Tom's research on hyperbilirubinemia in neonates.

    Faculty:  Tom Newman

    Location:  MB-Genentech Hall 106, Byers Auditorium

    Faculty Bio: Tom is Professor Emeritus of Epidemiology & Biostatistics and Pediatrics and former Chief of the Division of Clinical Epidemiology at the University of California, San Francisco School of Medicine.   He received his undergraduate degree from UC Santa Cruz, MD from UC San Diego, Residency Training in Pediatrics at UCSF and MPH in Epidemiology from UC Berkeley.  Tom attends in the newborn nursery at the UCSF Children's Medical Center and in the pediatric urgent care clinic at Zuckerberg San Francisco General Hospital.  Most of his research has used existing data to answer clinically relevant research questions.  He has a major role in UCSF's Training in Clinical Research (TICR) Program, and is a coauthor of two of the textbooks used in that training program: Designing Clinical Research and Evidence-Based Diagnosis.  He is on the Steering Committee of the Greater SF Bay Area Chapter of Physicians for Social Responsibility (PSR), chairs its Environmental Health Committee and recently completed 9 years on PSR's national Board of Directors.  He received the Academic Pediatric Association's Research Award in 2004, the American Academy of Pediatrics' Elizabeth Leistikow Award for Promotion of Evidence-based Pediatrics and the Stephen B. Hulley Award for Excellence in the Teaching of Clinical Research in 2010, the first UCSF Faculty Sustainability Award in 2011, and the Academic Pediatric Association's Miller-Sarkin mentoring award in 2017. 

    • Session Slides:

    • Lecture 2 slides File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Watch URL
      Not available unless: You belong to Registered Students Only

    • Pre-recorded version of lecture from prior year (Access restricted to registered students):

    • Tom Newman - Lecture 2, Part 1 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Tom Newman - Lecture 2, Part 2 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Tom Newman - Lecture 2, Part 3 Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Assignment 2

    • Assignment 2 File
    • Assignment 2 Example File

    • Materials:

    • Tom Newman: How do we know what we know? URL
    • Mark Pletcher - Mini-lecture - Study Design Basics Media Resource
      Not available unless: You belong to Registered Students Only

    • Optional reading from Tom Newman relevant to his Subjects and Variables lecture:

    • Newman 2006 NEJM Outcomes of TB 25 or more File
    • Newman 1991 AJDC Direct Bilirubin Measurements in Jaundiced Term Newborns File
    • Newman 2003 Stories Statistics BMJ File

  • Tuesday, August 7, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Tuesday, August 14, 2018; 9:00 AM - 10:00 AM

    Special "Quiz" Format Discussion on Sample Size, P-Values and Confidence Intervals

    Recorded lecture segments by Steve Cummings: An introduction to the concepts and information needed to estimate sample sizes for various types of studies. It includes suggestions for making more affordably sized studies.

    In-class "Quiz":  Please come in person to participate in a "competitive" in-class Quiz with discussion of sample size planning and related statistical concepts.

    Faculty: Mark Pletcher and Steve R. Cummings

    Location:  MB-Genentech Hall 106, Byers Auditorium

    Faculty Bio: Steve is a UCSF-trained general internist who led the UCSF Division of General Internal Medicine for a decade. He has spent almost 40 years designing, conducting, and teaching about clinical research.  He founded and directs the S.F. Coordinating Center that has designed, led, and conducted many large multicenter clinical trials and cohort studies.  He co-founded the Clinical Research Training program and co-authors Designing Clinical Research.  He is an Professor of Medicine, Epidemiology and Biostatistics at UCSF and also Senior Scientist at the CPMC Research Institute.  Steve’s own research has focused mainly on predicting and preventing fractures and understanding the biological basis of aging.  He has published over 500 peer-reviewed papers and has received numerous awards for his research in osteoporosis and women’s health, and was elected to the Institute of Medicine (now the National Academy of Medicine) for his work in clinical research in general and women’s health in particular.

    • Session Slides:

    • Lecture 3 - Steve Cummings - Sample Size File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Steve Cummings - Lecture 3, Part 1 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Steve Cummings - Lecture 3, Part 2 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Steve Cummings - Lecture 3, Part 3 Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Assignment 3:

    • Assignment 3 File
    • Assignment 3 Example File

    • Materials:

    • Bacchetti 2010: Current sample size conventions: Flaws, harms and alternatives File
      Not available unless: Your ID number contains 02
    • Statistical Interpretation of Data (Chapter from Goldman Textbook of Medicine, 24th ed, by Tom and Chuck). Note material in green is included only in the online text, hence it is not what is most important. File
      Not available unless: Your ID number contains 02
    • Sample size calculator (CTSI) URL
    • Sample size calculator (Quesgen) URL
    • Downloadable sample size program URL

  • Tuesday, August 14, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Tuesday, August 21, 2018; 9:00 AM - 10:00 AM

    Lecture: Observational Designs and Studies of Diagnostic Tests

    Format: In-class lecture

    Topic: Review common study designs, discuss how to choose what's right for your research question; also describe studies of diagnostic tests.

    Faculty: Warren Browner, MD MPH

    Location:  MB-Genentech Hall 106, Byers Auditorium

    Faculty Bio: Dr. Warren Browner is CEO  of California Pacific Medical Center (CPMC), a Senior Scientist in the CPMC Research Institute, and Professor (adjunct) of Epidemiology & Biostatistics at UCSF.  He previously was Professor of Medicine and of Epidemiology & Biostatistics at UCSF; Chief of General Internal Medicine and Acting Chief of the Medical Service at the San Francisco VA, and Vice President, Academic Affairs at CPMC.  He received an A.B. from Harvard, an M.D. from UCSF, and an M.P.H. in Epidemiology from Berkeley; he completed a residency in internal medicine and a fellowship in clinical epidemiology at UCSF. He has been a member of panels for the National Institutes of Health, the Department of Veterans Affairs, the Agency for Health Care Policy and Research, the Food and Drug Administration, and the California Hospital Association’s Hospital Quality Institute. He is the author of Publishing and Presenting Clinical Research, a co-author of Designing Clinical Research, and was the Executive Editor of the American Journal of Medicine.  He received a Distinguished Teaching Award from the UCSF Academic Senate in 1988; was one of UCSF’s 125 Distinguished Employees in 1989; and one of 150 Distinguished Alumni of UCSF in 2015. He serves on the Board of the San Francisco Chamber of Commerce and is the Immediate Past-Chair of the Board of the Jewish Community Center of San Francisco. He has lived in San Francisco since 1975, when he moved here to attend medical school.

  • Tuesday, August 21, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Tuesday, August 28, 2018; 9:00 AM - 10:00 AM

    Drop-in casual discussion with Mark Pletcher

    Format: Mark Pletcher will be in our usual lecture hall and available to talk about the topic of the week (below), student projects, or other issues as requested by students that wish to come.  NOTE: make sure to watch the recorded lecture by Deborah Grady - it's critical conceptual material, and a great lecture.

    Topic: Confounding, other problems with inferring causality; benefits, design, and pitfalls of randomized trials.

    Faculty:  Mark Pletcher, MD MPH

    Location: MB-Genentech Hall 106, Byers Auditorium

    • Session Slides:

    • Lecture 5 slides - pre-recorded lecture by Deborah Grady File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Deborah Grady’s lecture on Causal Inference URL
      Not available unless: You belong to a group in Registered Students Only

    • Assignment 5:

    • Assignment 5 File
    • Assignment 5 Example File

    • Materials:

    • Optional reading, especially for students designing studies of diagnostic tests:

    • Page proofs, Evidence-Based Diagnosis, Chapter 7 File
      Not available unless: Your ID number contains 02
    • Page proofs, Evidence-Based Diagnosis, Chapter 8 File
      Not available unless: Your ID number contains 02

  • Tuesday, August 28, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Tuesday, September 4, 2018; 9:00 AM - 10:00 AM

    Lecture: Questionnaires, Data Collection Forms and Data Management

    Format: In-class lecture

    Topic: Development of paper and online questionnaires and data collection forms. The limitations of spreadsheet programs (e.g. Excel) for database management. Alternative software platforms for data collection and management.

    Faculty:  Michael Kohn
     
    Location:      MB-Genentech Hall 106, Byers Auditorium

    Faculty Bio: Michael Kohn is an attending emergency physician at Mills-Peninsula in Burlingame and a professor in UCSF’s Department of Epidemiology and Biostatistics, where he has taught research methods, clinical epidemiology, and database management for the past 17 years.  He also provides consultations to clinical investigators who need help with study design, sample size calculations, data management, and statistical analysis.  His primary research interest is diagnostic testing in the ED.  He co-authored (with Thomas Newman) the clinical epidemiology textbook “Evidence-Based Diagnosis,” is a contributing author to Hulley et al, “Designing Clinical Research,” and created the UCSF CTSI’s online sample size calculators (www.sample-size.net).

  • Tuesday, September 4, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Tuesday, September 11, 2018; 9:00 AM - 10:00 AM

    Lecture: Learning Healthcare System Research Projects

    Format: In-class lecture

    Topic: What is meant by a Learning Healthcare System, how are LHS projects different than other research projects, introduction to implementation science

    Faculty:  Mark Pletcher
     
    Location:      MB-Genentech Hall 106, Byers Auditorium

  • Tuesday, September 11, 2018; 10:10 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Christian Apfel,Ingrid Chen, Matthew Cooperberg, Jason Flatt, Laura Jelliffe, Cassie Kline, Farzad Moazed, Megie Okumura, Meyeon Park, Joel Simon, Jennifer Smith, Jacqueline Torres, and Melisa Wong in San Francisco; Helen Byakwaga in Uganda
     
    Location: Apfel MH-1105, Chen MH-1405, Cooperberg Online,  Flatt MH-2109, Jelliffe MH-1107, Kline MH-2110, Moazed MH-2108, Okumura MH-2106, Park MH-1109, Simon MH-1108, Smith MH-2105,  Torres MH-1106, Wong MH- 2107, Byakwaga Online-Uganda
     

  • Monday, September 17, 2018

    Protocols DUE 5:00 PM