EPI 202: Designing Clinical Research (Two Month) (Summer 2020)

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    Designing Clinical Research (Two Month) EPI 202 Summer 2020 (2 units). Course Director: Mark Pletcher, MD, MPH. Professor, Department of Epidemiology & Biostatistics

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• Select section Tuesday, July 28, 2020; 9:45 AM - 10:00 AM

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  Tuesday, July 28, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

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

  Course history and objectives; course schedule and logistics; 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; systematic reviews.
  

  Faculty: Mark Pletcher
  

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    Other protocol formats and examples (FYI only):

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    Protocol format for ClinicalTrials.gov File
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• Select section Tuesday, July 28, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, July 28, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section (see Roster for your section assignment)
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
   
  Location: Zoom URL (links to a document listing all of the Zoom URLs)
  

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• Select section Friday, July 31, 2020; 10:00 AM - 11:00 AM

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  Friday, July 31, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, August 4, 2020; 9:00 AM - 9:45 AM

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  Tuesday, August 4, 2020; 9:00 AM - 9:45 AM

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  Location (Access restricted to registered students): Zoom URL
  
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  Tuesday, August 4, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

  Topic: Subjects and Variables

  Faculty: Tom Newman, MD, MPH
  
  Location (Access restricted to registered students):  Zoom URL
  

  Faculty Bio: Tom is Professor Emeritus of Epidemiology & Biostatistics and Pediatrics at UCSF. 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. He was chief of the Division of Clinical Epidemiology from 2001-2016. Though semi-retired, Tom still attends in the newborn nursery at the UCSF Children's Medical Center. Most of his research has focused on avoiding overuse and improving healthcare value. He is a coauthor of the Designing Clinical Research textbook, as well as Evidence-Based Diagnosis (used for Epi 204; 2nd edition due out this Fall). He is on the Board of Directors 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 has received the Academic Pediatric Association's Research Award, the American Academy of Pediatrics' Elizabeth Leistikow Award for Promotion of Evidence-based Pediatrics, the Stephen B. Hulley Award for Excellence in the Teaching of Clinical Research, the UCSF Faculty Sustainability Award, and the Academic Pediatric Association's Miller-Sarkin mentoring award.
  

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    Schroeder et al 2011 Pediatrics Safely doing less File
• Select section Tuesday, August 4, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, August 4, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
• Select section Friday, August 7, 2020; 10:00 AM - 11:00 AM

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  Friday, August 7, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, August 11, 2020; 9:00 AM - 9:45 AM

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  Tuesday, August 11, 2020; 9:00 AM - 9:45 AM

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  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, August 11, 2020; 9:45 AM - 10:00 AM

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  Tuesday, August 11, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

  Topic: Sample Size, P-Values and Confidence Intervals

  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.

  Faculty: Steve R. Cummings
  
  Location (Access restricted to registered students):  Zoom URL
  

  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.
  

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• Select section Tuesday, August 11, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, August 11, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
• Select section Friday, August 14, 2020; 10:00 AM - 11:00 AM

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  Friday, August 14, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, August 18, 2020; 9:00 AM - 9:45 AM

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  Tuesday, August 18, 2020; 9:00 AM - 9:45 AM

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  Course faculty are available for interactive discussion and to address questions.  
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, August 18, 2020; 9:45 AM - 10:00 AM

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  Tuesday, August 18, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

  Topic: Observational Designs and Studies of Diagnostic Tests

  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 (Access restricted to registered students):  Zoom URL
  

  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.
  

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• Select section Tuesday, August 18, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, August 18, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
• Select section Friday, August 21, 2020; 10:00 AM - 11:00 AM

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  Friday, August 21, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, August 25, 2020; 9:00 AM - 9:45 AM

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  Tuesday, August 25, 2020; 9:00 AM - 9:45 AM

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  Location (Access restricted to registered students): Zoom URL
  
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  Tuesday, August 25, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

  Topic: Causal Inference and Randomized Trials

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

  Faculty: Mark Pletcher, MD MPH
  
  Location (Access restricted to registered students):  Zoom URL
  

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• Select section Tuesday, August 25, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, August 25, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
• Select section Friday, August 28, 2020; 10:00 AM - 11:00 AM

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  Friday, August 28, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, September 1, 2020; 9:00 AM - 9:45 AM

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  Tuesday, September 1, 2020; 9:00 AM - 9:45 AM

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  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, September 1, 2020; 9:45 AM - 10:00 AM

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  Tuesday, September 1, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

  Topic: Questionnaires, Data Collection Forms and Data Management

  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 (Access restricted to registered students):  Zoom URL
  

  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).
  

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• Select section Tuesday, September 1, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, September 1, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
• Select section Friday, September 4, 2020; 10:00 AM - 11:00 AM

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  Friday, September 4, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, September 8, 2020; 9:00 AM - 9:45 AM

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  Tuesday, September 8, 2020; 9:00 AM - 9:45 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Tuesday, September 8, 2020; 9:45 AM - 10:00 AM

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  Tuesday, September 8, 2020; 9:45 AM - 10:00 AM

  Course Announcements and Weekly Curriculum
  

  Topic: Use Electronic Health Records for Research

  Faculty: Mark Pletcher, MD MPH
  
  Location (Access restricted to registered students):  Zoom URL

  • Select activity Announcements Audio/Video Recording:  (copy) (copy) (copy) (copy) (copy)

    Announcements Audio/Video Recording: 
    

  • Select activity To be available after session (copy) (copy) (copy) (copy) (copy)

    To be available after session

  • Select activity Lecture Slides: (copy) (copy) (copy) (copy) (copy)

    Lecture Slides:

  • Select activity Lecture 7 Slides (Mark Pletcher) - Using EHR Data for Research

    

    Lecture 7 Slides (Mark Pletcher) - Using EHR Data for Research File
  • Select activity Mark Pletcher - Learning Health System Research Projects

    

    Mark Pletcher - Learning Health System Research Projects File
  • Select activity Lecture Audio/Video Recording (Access restricted t... (copy) (copy) (copy) (copy) (copy)

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

  • Select activity Lecture 7 (Mark Pletcher) - Using EHR Data for Research (recorded live lecture)

    

    Lecture 7 (Mark Pletcher) - Using EHR Data for Research (recorded live lecture) URL

    Not available unless: You belong to Registered Students Only
  • Select activity Mark Pletcher - Learning Healthcare System Research Projects (recorded live lecture)

    

    Mark Pletcher - Learning Healthcare System Research Projects (recorded live lecture) URL

    Not available unless: You belong to Registered Students Only
  • Select activity Assignment 7:

    Assignment 7:
  • Select activity Assignment 7

    

    Assignment 7 File
  • Select activity Materials:

    Materials:

  • Select activity Stata .do files from lecture demonstration

    

    Stata .do files from lecture demonstration Folder
  • Select activity Stata "How to" handouts relevant to EHR data analysis

    

    Stata "How to" handouts relevant to EHR data analysis Folder
• Select section Tuesday, September 8, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

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  Tuesday, September 8, 2020; 10:10 AM - 12:00 PM (Additional sessions: Tuesday 6 - 8 PM; and Wednes. 8 to 10 AM)

  Small Group Discussion Section
  

  Review of prior lecture and problem set
  

  Faculty: Benjamin Breyer, Megumi Okumura, Joel Simon, Ali Mirzazadeh, Pam Murnane, Catie Oldenburg, Erin Van Blarigan, Yeyi Zhu, Jennifer Smith, Sunitha Kaiser, Mohammad Kazem Fallahzadeh, Stephanie Frazin
• Select section Friday, September 11, 2020; 10:00 AM - 11:00 AM

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  Friday, September 11, 2020; 10:00 AM - 11:00 AM

  Office Hours

  Course faculty are available for interactive discussion and to address questions.  
  

  Faculty: Mark Pletcher
  

  Location (Access restricted to registered students): Zoom URL
  
• Select section Monday, September 14, 2020

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  Monday, September 14, 2020

  Protocol Due: 5:00 PM

  • Select activity Final Project Instructions: Upload 5-page resea...

    Final Project Instructions:

    • Upload 5-page research protocols by 5 PM
    • Strict 5-page limit, 12-point font, 1-inch margins all around.
    • You may only upload a single document.  Please use Microsoft Word if you can, so we have the option of using track changes and suggestions.  PDF format is also acceptable.  If you want to submit Appendices, they must be included at the end of your document.
    • Please name it "LastnameFirstname_FinalProtocol2020" (substituting your name)
    • See Template and Examples for Guidance.  Reasonable modifications and omissions are fine.
  • Select activity Upload Final Project here

    

    Upload Final Project here Assignment
  • Select activity Final project template and examples:

    Final project template and examples:

  • Select activity Template for 5-page protocol

    

    Template for 5-page protocol File
  • Select activity Example 5-page protocol ADAIR Study French 2013

    

    Example 5-page protocol ADAIR Study French 2013 File
  • Select activity Example 5-page protocol Chlamydia screening Sufrin

    

    Example 5-page protocol Chlamydia screening Sufrin File
  • Select activity Sufrin Published paper based on DCR Protocol

    

    Sufrin Published paper based on DCR Protocol File
  • Select activity Other Resources:  The CTSI has a K library h...

    Other Resources: 

    The CTSI has a K library here: 

    http://accelerate.ucsf.edu/training/grants-library

    See the UCSF Office of Sponsored  Research for information about funding,

    http://osr.ucsf.edu/content/find-funding-opportunities 

    including a database to which the library subscribes called PIVOT:  

    http://www.library.ucsf.edu/db/pivot-funding-opportunities-researcher-profiles