Designing Clinical Research (One Month)

EPI 150.03 Summer 2020 (2 units)
Course Director: Alison Huang, MD, MAS
Associate Professor
Department of Medicine and Department of Epidemiology and 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 introductory skills 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 or enrollment in the UCSF Pre-Health Undergraduate Program (PUP) or SF-BUILD program.
  • 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:

Alison Huang, MD, MAS
Associate Professor, Department of Medicine and Department of Epidemiology & Biostatistics
Phone: 415-514-8697
email: alison.huang@ucsf.edu

Co-Course Director:

Megumi Okumura, MD, MAS
Associate Professor, Department of Pediatrics
email: Megumi.Okumura@ucsf.edu

Lecturers: Kirsten Bibbins-Domingo, MD, PhD, MAS
Chair, Department of Epidemiology and Biostatistics
email: bibbinsk@medicine.ucsf.edu
  Alka Kanaya, MD
Professor, Departments of Medicine and Department of Epidemiology & Biostatistics
email: Alka.kanaya@ucsf.edu
  Vanessa Jacoby, MD, MAS
Professor, Departments of Obstetrics, Gynecology, & Reproductive Sciences
email: vanessa.jacoby@ucsf.edu
  Deborah Grady, MD
Professor Emeritus, Department of Medicine
email: deborah.grady@ucsf.edu
  Charles McCulloch, PhD
Professor, Departments of Medicine and Epidemiology & Biostatistics
email: charles.mcculloch@ucsf.edu
  Thomas Newman, MD
Professor Emeritus, Departments of Epidemiology & Biostatistics and Pediatrics
email: newman@epi.ucsf.edu
  Doug Bauer, MD
Professor, Departments of Medicine and Epidemiology & Biostatistics
email: dbauer@psg.ucsf.edu
  Steve Cummings, MD
Professor Emeritus, Departments of Medicine and Epidemiology & Biostatistics
email: scummings@sfcc-cpmc.net
Resident Section Leaders: Beth Cohen, MD, MAS
email: beth.cohen@ucsf.edu
  Amy Beck, MD, MPH
email: Amy.Beck@ucsf.edu
  Amy Padula, PhD
email: Amy.Padula@ucsf.edu
  Valerie Flaherman, MD
email: Valerie.Flaherman@ucsf.edu
  Meghana Gadgil, MD, MPH
email: Meghana.Gadgil@ucsf.edu
Non-Resident Section Leaders: TBA
FORMAT

For each of 7 blocks (twice each week for 3.5 weeks), curricular material is introduced with a lecture and accompanying reading. Each block will focus on a new component of a research protocol, which students will discuss with faculty at the twice-weekly (Monday and Wednesday) small group discussion section.

  1. Lectures: For each block, beginning on August 3, a pre-recorded lecture provides an overview of the curricular material for the block. The video is available on the course website and can be viewed at the student's convenience.
  2. Small Group Sections:
    Content: Review of assigned protocol components and discussion of readings and exercises.
    Most small small group sections will be held on Mondays and Wednesdays from 10:30 AM to 12:00 Noon, beginning on Aug 3. A smaller number will be available at 8:30 AM to 10 AM and at 5:30 PM to 7:00 PM. All small groups will convene by Zoom webconferencing software.
  3. Final Protocol Review: Protocols are due (via e-mail) by Wednesday, August 26. Student pairs or trios meet with a different faculty member to evaluate their protocols.

For each of the 7 blocks, students will:

  • Watch the lecture
  • Read portions of Designing Clinical Research (DCR-4)
  • Complete the exercises
  • Compose parts of your protocol (specific assignments in the syllabus section). Students are asked to bring the first draft of their homework to small group section. Revisions can subsequently be emailed to section leaders by MIDNIGHT
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 groups 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 fees 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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