Designing Clinical Research (Two Month)

EPI 202 Summer 2020 (2 units)
Course Director: Mark J. Pletcher, MD, MPH
Professor
Department of Epidemiology & Biostatistics

OBJECTIVES

This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research. This is primarily accomplished by instructing students in the creation of a research protocol that is intended to address a relevant research question in their specific area of interest.

The objectives for this course are for participants to:

  • acquire an introductory skill set for designing and interpreting clinical research;
  • produce a complete clinical research protocol, including background, sampling, measurements, and data analysis; and
  • help others in the class to develop these skills and protocols.
PREREQUISITES
  • Possession of at least an undergraduate degree.
  • An idea for a research question in clinical research that has been discussed with an experienced investigator.
  • Proficiency with word processing software, biomedical literature searching with Pubmed, and reference management software (Endnote, RefWorks or other software).
FACULTY
Course Director: Mark Pletcher, MD, MPH
Phone: 415-514-8008
Professor of Epidemiology & Biostatistics
email: mpletcher@epi.ucsf.edu
Course Co-Director: Joel Simon, MD, MPH
Professor Emeritus, Departments of Medicine and Epidemiology & Biostatistics
email: joel.simon@ucsf.edu
Lecturers: Warren Browner, MD, MPH
CEO, California Pacific Medical Center; Professor of Medicine and Epidemiology & Biostatistics
email: warren@cpmcri.org
  Steve Cummings, MD
Professor Emeritus, Departments of Medicine and Epidemiology & Biostatistics
email: scummings@sfcc-cpmc.net
  Deborah Grady, MD
Professor Emeritus, Department of Medicine
email: Deborah.Grady@ucsf.edu
  Michael Kohn, MD, MPP
Professor, Department of Epidemiology & Biostatistics
email: michael.kohn@ucsf.edu
  Thomas Newman, MD
Professor Emeritus, Departments of Epidemiology & Biostatistics and Pediatrics
email: newman@epi.ucsf.edu
Section Leaders: Benjamin Breyer, MD, MAS
email: Benjamin.Breyer@ucsf.edu
  Laura Jelliffe, PhD, MS
email: Laura.Jelliffe@ucsf.edu
  Megumi Okumura, MD, MAS
email: Megumi.Okumura@ucsf.edu
  Joel Simon, MD, MPH
email: Joel.Simon@ucsf.edu
  Ali Mirzazadeh, PhD, MD, MPH
email: Ali.Mirzazadeh@ucsf.edu
  Pam Murnane, PhD
email: Pam.Murnane@ucsf.edu
  Catie Oldenburg, ScD, MPH
email: Catie.Oldenburg@ucsf.edu
  Erin Van Blarigan, ScD
email: Erin.Vanblarigan@ucsf.edu
  Yeyi Zhu, PhD
email: Yeyi.Zhu@ucsf.edu
  Jennifer Smith, PhD
email: Jennifer.Smith@ucsf.edu
  Sunitha Kaiser, MD
email: Sunitha.Kaiser@ucsf.edu
FORMAT

Each week, for seven weeks, curricular material is introduced with a lecture and accompanying reading. Each week will focus on a new component of a research protocol, which students will discuss with faculty at the weekly small group discussion section.

  1. Lectures: Each week, a pre-recorded lecture provides an overview of the curriculum material for the week. The video is available on the course website and can be viewed at the student's convenience.
  2. Interactive Discussion: Tuesdays, 9:00 AM to 9:50 AM, July 28 through September 8.
    The Course Director and a weekly guest expert field questions about the week's curriculum and provide insights from the guest's research career.
  3. Small Group Sections:
    Content: Review of assigned protocol components and discussion of readings and exercises.
    Most small small group sections will be held on Tuesdays from 10:00 AM to 12:00 Noon, beginning on July 28. A smaller number will be available on Tuesdays at 6:00 PM to 8:00 PM and Wednesdays from 8:00 AM to 10:00 AM. All small groups will convene by Zoom webconferencing software.

Weekly assignments will generally include:

  • Watching the lecture
  • Reading portions of Designing Clinical Research (DCR-4)
  • Doing DCR-4 exercises (optional)
  • Composing parts of your protocol (specific assignments in the syllabus section). Students are asked to bring the first draft of their homework (on paper) to section on TUESDAY. Revisions can subsequently be emailed to small group section leaders by MIDNIGHT WEDNESDAY.

All course materials and handouts will be posted on the course's online syllabus.

MATERIALS

Required:
Designing Clinical Research
by Stephen B. Hulley, MD, MPH et al. Wolters Kluwer. 4th Edition. 2013. UCSF library call number: R853.C55 D47.

Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).

GRADING

Students are expected to attend all small group sections with only ONE excused absence permitted, and students are expected to inform their small group section leaders beforehand about any absence. Participation in small groups, timely completion of reading assignments and problems sets, and final submission of a completed protocol are minimum requirements for a passing grade.

Students not in full-year TICR Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion

UCSF Graduate Division Policy on Disabilities

TO ENROLL

To apply for this course, please fill out and submit the application below. Please see our fee page for cost information. The deadline for application is July 13, 2020. Only one application needs to be completed for all courses desired during the quarter.

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APPLICATION Information for how to pay;
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