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Syllabus

Designing Clinical Research EPI202

Date/Time Activity Topic/Content Faculty Locations
Tues 8/4/2009
9:10 AM-10:00 AM		Lecture

Intro to the Course and to Clinical Research; Research Questions

Required Reading:

  1. Chapter 1: The Anatomy and Physiology of Clinical Research
  2. Chapter 2: Conceiving the Research Questions

Optional Reading:

  1. Survival Guide for Generalist Physicians in Academic Fellowships.

Note/Slide Files: 09 DCR lect 1 slides TN3Aug09.ppt (1927 KB) lecture_TNewman_08042009.swf (28820 KB) video_08042009.mov (79636 KB)

Assignment Files: 09 DCR 1stAssignment Endnote RefWorks.doc (33 KB)

T NewmanHSW-302
Tues 8/4/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment:
Please bring a hard copy of the Session 1 Assignment (Researach Question and Significance Sesction) to class today. You will discuss it with your section mates and email it to your section leader by midnight tonight.

Assignment Files: 09-Session 1 assignment.doc (26 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 8/11/2009
9:10 AM-10:00 AM		Lecture

Subjects and Variables

Required Reading:

  1. Chapter 3: Choosing the Subjects: Specification, Sampling & Recruitment
  2. Chapter 4: Planning the Measurements: Precision and Accuracy

Optional Reading:

  1. Marketing Medicines with Research, Slides 1-25 (Articulate(R) Presentation by TBN; you’ll need headphones or speakers and you may need to ignore a warning.) Feel free to listen to the whole thing if you have time.

Note/Slide Files: lecture_AGo_08112009.swf (43619 KB) Subjects-Variables-Handout-2009-08-11.ppt (1699 KB) video_08112009.mov (94883 KB)

A GoHSW-302
Tues 8/11/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment Files: 09-Session 2 assignment.doc (29 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 8/18/2009
9:10 AM-10:00 AM		Lecture

Sample size, P-values and Confidence Intervals

Required Reading:

  1. Chapter 5: Getting Ready to Estimate Sample Size: Hypotheses & Underlying Principles
  2. Chapter 6: Estimating Sample Size & Power

Optional Reading:

  1. Online Sample Size Calculators

Note/Slide Files: 81809_export.mov (81721 KB) lecture_SCummings_08182009.swf (33292 KB) Sample Size DCR 2009 to post.ppt (1080 KB)

Tool Files: MAKohnSampleSizeCalculators.xls (79 KB)

S CummingsHSW-302
Tues 8/18/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment Files: 09-Session 3 assignment.doc (31 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 8/25/2009
9:10 AM-10:00 AM		Lecture

Observational Designs and Studies of Diagnostic Tests

Required Reading:

  1. Chapter 7: Designing a Cohort Study
  2. Chapter 8: Designing Cross-Sectional and Case-Control Studies
  3. Chapter 12: Designing Studies of Medical Tests
  4. Chapter 13: Utilizing Existing Databases

Optional Reading:

  1. Chapter 1 and 5 of EBD if you are stydying a test

Note/Slide Files: 08_25_09_export.mov (85579 KB) 08_25_2009_lecture.swf (32576 KB) KohnObservationalStudyDesign_08-25-2009 for posting.ppt (666 KB)

M KohnHSW-302
Tues 8/25/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment Files: 09-Session 4 assignment.doc (28 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 9/1/2009
9:10 AM-10:00 AM		Lecture

Confounding and Causal Inference

Required Reading:

  1. Chapter 9: Enhancing Causal Inference in Observational Studies
  2. Chapter 10: Designing a Randomized Blinded Trial
  3. Chapter 11: Alternative Trial Designs and Implementation Issues

Optional Reading:

  1. Chapter 10 of EBD

Note/Slide Files: 09_01_09_export.mov (74134 KB) 09_01_2009.swf (23600 KB) Confounding.ppt (202 KB)

W BrownerHSW-302
Tues 9/1/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment Files: 09-Session 5 assignment.doc (28 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 9/8/2009
9:10 AM-10:00 AM		Lecture

Randomized trials

Required Reading:

  1. Chapter 12: Designing Studies of Medical Tests
  2. Chapter 13: Utilizing Existing Databases
  3. Chapter 15: Designing Questionnaires and Interviews
  4. Chapter 16: Data Management

Note/Slide Files: 090809_Export.mov (83021 KB) 09082009.swf (29825 KB) DCR Clinical Trials 09.ppt (364 KB)

D GradyHSW-302
Tues 9/8/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment Files: 09-Session 6 assignment.doc (27 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 9/15/2009
9:10 AM-10:00 AM		Lecture

Study Design and Statistical Analysis

Required Reading:

  1. Chapter 17: Implementing the Study and Quality Control
  2. Chapter 19: Writing and Funding a Research Proposal

Note/Slide Files: 09_15_09.mov (78270 KB) 09_15_2009.swf (27449 KB) Katz, A Conceptual Approach to Statistics.ppt (1579 KB)

M KatzHSW-303
Tues 9/15/2009
10:10 AM-12:00 PM		Section

Designing Clinical Research section

Assignment Files: 09-Session 7 assignment.doc (29 KB)

C Apfel
A Bryant
C Calfee
C Dehlendorf
K Greene
M Kohn
K Lee
T Newman
D Rehkopf
J Schmittdiel
J Simon
M Wintermark		U-456
U-506
C-417
C-517
N-417
U-458
N-617
U-460
S-172
S-170
N-527
N-423
Tues 9/22/2009
 		Other

Protocols DUE 5 PM

Assignment:
Please e-mail the protocol as a Microsoft Word attachment to Olivia De Leon at olivia@epi.ucsf.edu . She will use the return address to email your assignments for the final session back to you about a week later.

Assignment Files: 09 5-page protocol.doc (56 KB)

n/an/a
Tues 10/6/2009
8:15 AM-9:30 AM		Other

Protocol Review Session (Option #1)

Assignment Files: 09 Protocol Review Session Revised27Sep09.doc (29 KB)

n/an/a
Tues 10/13/2009
8:15 AM-9:30 AM		Other

Protocol Review Session (Option #2)

Assignment Files: 09 Protocol Review Session Revised27Sep09.doc (29 KB)

n/an/a