Epidemiology and Biostatistics
for the Clinical Research Scientist

Goals and Objectives

To enhance medical scientists' ability to understand the biostatistical and epidemiologic principles involved with clinical trials. Specific topic titles will include:

Review of disease classification, observational study designs, measures of disease frequency, and measure of association.
   
Discussion of early phase interventional research studies in humans.
   
Evidenced-based medicine at its best, complemented by a recent high-visibility example of the need for RCT's.
   
Considerations in preparing for a career as a clinical research scientist and defining your niche.

Course Structure and Organization
Click on a session title to watch online video of the presentation.

09/22/04
Clinical Research: The Final Path to Medical Discoveries
 Charles Prober, MD
Course introduction with overview of different types of clinical research and key members of clinical research team.
 


09/29/04
Basic Clinical and Epidemiological Research Principles
Rita Popat, PhD
Review of disease classification, observational study designs (focused on case-control and cohort designs), measures of disease frequency, and measures of association.
 


10/06/04
Causal Inference, Identifying and Minimizing Study Biases
Rita Popat, PhD
Discussion of scientific principles of causation and methods for optimizing validity of results.
 


10/13/04
Basic Biostatistical Principles for the Clinical Research Scientist
and

10/20/04
Biostatistics in Action: From Concept to Protocol
Kristin Cobb, PhD
These two presentations constitute a practical biostatistics primer, introducing critical concepts and methodologies while emphasizing critical need for early statistical consultation in design of clinical research studies.
 


11/02/04 *
Randomized Controlled Trial: The Holy Grail
Marcia Stefanick, PhD
(No video available for this presentation.)
Evidenced-based medicine at its best, complemented by a recent high-visibility example of the need for RCT’s.

 


11/10/04
The Process of Drug Studies and Approval in the United States
Terry Blaschke, MD
An introduction to the Food and Drug Administration and the process of drug discovery.
 


11/17/04
Optimal Design, Goals, and Limitations of Phase I and II Trials
Mark Genovese, MD
Discussion of early phase interventional research studies in humans.
 


11/24/04
Your First Clinical Trial: Get it Right the First Time
Darrell Wilson, MD
Practical considerations in conducting research projects.
 


12/01/04
Partnering with Industry
Leighton Reed, MD
The rewards and perils of the academic/industry interface.
 


12/09/04 *
Building an Academic Career as a Clinical Research Scientist
Phil Pizzo, MD
(No video available for this presentation.)
Considerations in preparing for a career as a clinical research scientist and defining your niche.

* All classes will be held on Wednesday evenings except for 11/02/04 (Tuesday) and 12/09/04 (Thursday); there is no class October 27. Classes will commence promptly at 5:30 p.m. and will end by 7:00 p.m. The meeting room is M-106 (School of Medicine).