PRECEPT
(primarily for Clinical Scientists)

Design and Conduct of Clinical Research & Trials

September 28 - December 7, 2006

Clinical Research Goals and Objectives

To enhance medical scientists' ability to understand the biostatistical and epidemiologic principles underpinning the appropriate design, execution, and analysis of hypothesis-driven research projects. Specific topic areas will include:

Fundamental principles of descriptive and inferential statistics, measurement, design, and analysis
   

Application of these principles to specific areas:

Randomized clinical trails
Medical test evaluation
Observational studies
Risk assessment
Mathematical simulation and modeling
Meta analysis

Clinical Trials Goals and Objectives

To expose participants to the relevance of the Food and Drug Act to the design and conduct of clinical trials.

 


To convey an understanding of the differences between Phase I, II, III, and IV Clinical Trials.
 


To develop a framework for understanding data management techniques, at both the macro (rapidly evolving technologies) and the micro (individual trials) level.
 


To emphasize the practical aspects of conducting clinical trials and how to avoid pitfalls and the need for rework.

 


To explore methods of conducting trials in complex patients and how to "connect" with national studies and industry.
 


To understand methods of translating the results of clinical trials to improved health and optimal patient outcomes.

Registration and Lecture Information

Lectures are one hour with discussion to follow and are delivered on Thursdays from 5:30pm - 7:00 pm, except the lecture on 11/30/06 will be from 5:00-6:15. Complete course materials will be available at the beginning of each lecture if applicable.

9/28/06
video Clinical Research: The Final Path to Medical Discoveries
Charles Prober, M.D.
Course introduction with overview of different types of clinical research, emerging trends and topics & key members of clinical research teams at Stanford
 


10/05/06
video Your First Clinical Trial: Get it Right the First Time
Darrell Wilson, MD
Practical Considerations in Conducting research projects
 


10/12/06
video The Process of Drug Studies & Approval in the United States
Karlene Cimprich, PhD & Daria Mochly-Rosen, PhD
An introduction to the Food and Drug Administration and the process of drug discovery
 


10/19/06
Case Studies in Uses of Patient Samples and Data - Clinical Focus
Sally Tobin, PhD
Interactive discussion on uses of patient samples and data that explore clinical aspects of patient care, privacy, security, confidentiality and ethics
 


11/02/06
video Optimal Design, Goals & Limitations of Phase I and II Trials
Mark Genovese, MD
Discussion of early phase interventional research studies in humans

 


11/09/06
video Randomized Controlled Trial: The Holy Grail
Marcia Stefanick, PhD
 Evidence-based Medicine at its best complemented by a recent high-visibility example of the need for RCTs
 


11/16/06
Casual Inference, Identifying and minimizing study biases
Rita Popat, PhD
 Review of disease classification observational study designs,(focused on case-control and cohort designs), measures of disease frequency & measures of association. Discussion of scientific principles of causation and methods for optimizing validity of results
 


11/30/06
video Building an Academic Career as a Clinical Research Scientist
Phillip Pizzo, MD
Considerations in preparing for a career as a clinical research scientist and defining your niche
 


12/07/06
video Privacy & Security Aspects of Biomedical Information
Management
Henry Lowe, MD & Todd Ferris MD, MS
Interactive discussion on use and management of biomedical information that explores data privacy, security, and confidentiality concerns