171:267
or 173:290 - Intervention and Clinical Trials
Fall,
2002
SCHEDULE: Lecture: Monday and Wednesday 10:30a-11:50a
Discussion: Friday 10:30a-11:50a
LOCATION: 1107 BSB
CREDIT: 3 Semester Hours
COURSE DIRECTORS: James Torner and William Clarke
PREREQUISITES: 173:140 or equivalent; 171:161 or
equivalent; consent of instructor
COURSE DESCRIPTION
The course is intended as a methodologic introduction to
the rational, design, conduct, analysis and presentation of clinical trials.
The course will provide the basics of clinical trial design and will use
examples from clinical trials that have been and are being conducted. The
student will be exposed to the variety of trial designs. Analysis will utilize
biostatistical methods in comparison and adjustment as well as sample size
determination.
COURSE OBJECTIVES
The overall objectives
are to increase the understanding of the student to:
1. The design features of clinical and
intervention trials
2.
The protocol content
3. The statistical methods used in design
and analysis
4. The issues in monitoring and reporting
results.
EVALUATION
Three examinations (75%)
Review of articles and
presentation (25%)
TEXT
LM Friedman, Curt
Furberg, David DeMets: Fundamentals of Clinical Trials. Springer
Verlag; ISBN: 0387985867; 3rd edition (November 1998)
If you are a person with a disability who requires
accommodation for this course,
please notify Drs Torner or Clarke.
|
Date |
Topic |
|
Instructor |
|
26-Aug |
Introduction
to Clinical Trials |
Chapter 1 |
Torner |
|
28-Aug |
Typology of
and Process of Clinical Trials |
Chapter 4 |
Torner |
|
30-Aug |
Discussion |
|
|
|
2-Sep |
No Class |
|
|
|
4-Sep |
Ethical
Considerations |
Page 8-9 |
Torner |
|
6-Sep |
IRB |
|
Wasek |
|
9-Sep |
Planning
-Sample Size |
Chapter 7 |
Clarke |
|
11-Sep |
Use of
Placebo - Articles |
|
|
|
13-Sep |
Planning
-Sample Size |
|
Clarke |
|
16-Sep |
Planning
-Organization |
Chapter 19 |
Torner |
|
18-Sep |
Planning
-Protocol Development: Intervention |
Chapter 2,
page 10 |
Torner |
|
20-Sep |
Discussion |
|
|
|
23-Sep |
Planning
-Randomization |
Chapter 5 |
Clarke |
|
25-Sep |
Planning
-Outcomes and Endpoints |
Chapter 6 |
Torner |
|
27-Sep |
Planning
-Outcomes: Cost-effectiveness, Quality of Life |
Chapter 12 |
Chrischilles |
|
30-Sep |
No Class |
|
|
|
2-Oct |
EXAM |
|
|
|
4-Oct |
PIC |
|
|
|
7-Oct |
Planning
-Data Collection Form Development |
|
Wichman |
|
9-Oct |
Planning
-Training |
|
Wichman |
|
11-Oct |
No Class |
|
|
|
14-Oct |
Data
Management |
Chapter 10 |
Clarke |
|
16-Oct |
Execution
-Recruitment |
Chapter 9 |
Torner |
|
18-Oct |
Discussion |
|
|
|
21-Oct |
Execution
-Monitoring of Adverse Events |
Chapter 11 |
Wallace |
|
23-Oct |
Execution
-Adherence and Compliance |
Chapter 13 |
|
|
25-Oct |
Discussion |
|
|
|
28-Oct |
Execution
-Closeout Procedures |
Chapter 17 |
Torner |
|
30-Oct |
EXAM |
|
|
|
1-Nov |
CTDMC |
|
|
|
4-Nov |
Coding,
Analysis and Reporting -Adverse Events
|
Chapter 11 |
Torner |
|
6-Nov |
Analysis
-Efficacy Analysis |
Chapter 8 |
Clarke |
|
8-Nov |
Dr. Adams |
|
|
|
11-Nov |
Analysis
-Efficacy Analysis |
Chapter 14 |
Clarke |
|
13-Nov |
Analysis
-Efficacy Analysis |
Chapter 16 |
Clarke |
|
15-Nov |
Discussion |
|
|
|
18-Nov |
Reporting
-Outcomes and Publication Procedures |
Chapter 18 |
Torner |
|
20-Nov |
Analysis -Subgroup Analysis |
|
Clarke |
|
22-Nov |
Discussion |
|
|
|
25-Nov |
Analysis
-Interim Analysis |
Chapter 15 |
Clarke |
|
27-Nov |
No Class |
|
|
|
29-Nov |
No Class |
|
|
|
2-Dec |
Analysis
-Interim Analysis |
Chapter 15 |
Clarke |
|
4-Dec |
Cost and
Funding |
|
Torner |
|
6-Dec |
Discussion |
|
|
|
9-Dec |
Presentations |
|
Students |
|
11-Dec |
Presentations |
|
Students |
|
13-Dec |
Presentations |
|
Students |
|
16-Dec |
FINAL EXAM |
|
|