Introduction to Clinical Trials
Κωνσταντίνος Γιαννούτσος
1. Description
This is a standard course that prepares Biostatisticians for support of clinical trial projects. The course will cover fundamental aspects of the appropriate design and conduct of medical experiments involving human subjects (clinical research/trials) including ethics, design, sample size calculation, randomization, monitoring, data collection analysis and reporting of the results.
There will be three homework projects assigned with about four weeks allowed for completion, plus one midterm examination and a final class project. The relative importance of these in the final grade is given below.
A computer laboratory will accompany some (but not all) lectures.
2. Prerequisites/Audience
Analysis of variance, regression and survival analysis is assumed and general familiarity with clinical trials will be helpful.
3. Textbooks
- Clinical Trials. A methodologic perspective by Steven Piantadosi John Wiley & Sons, New York
- Also, Fundamentals of Clinical Trials, Third Edition by Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets. Springer
- Clinical trials by Stuart J. Pocock. John Wiley & Sons, New York
- Notes and handouts provided by the instructor.
1. Description
This is a standard course that prepares Biostatisticians for support of clinical trial projects. The course will cover fundamental aspects of the appropriate design and conduct of medical experiments involving human subjects (clinical research/trials) including ethics, design, sample size calculation, randomization, monitoring, data collection analysis and reporting of the results.
There will be three homework projects assigned with about four weeks allowed for completion, plus one midterm examination and a final class project. The relative importance of these in the final grade is given below.
A computer laboratory will accompany some (but not all) lectures.
2. Prerequisites/Audience
Analysis of variance, regression and survival analysis is assumed and general familiarity with clinical trials will be helpful.
3. Textbooks
- Clinical Trials. A methodologic perspective by Steven Piantadosi John Wiley & Sons, New York
- Also, Fundamentals of Clinical Trials, Third Edition by
1. Description
This is a standard course that prepares Biostatisticians for support of clinical trial projects. The course will cover fundamental aspects of the appropriate design and conduct of medical experiments involving human subjects (clinical research/trials) including ethics, design, sample size calculation, randomization, monitoring, data collection analysis and reporting of the results.
There will be three homework projects assigned with about four weeks allowed for completion, plus one midterm examination and a final class project. The relative importance of these in the final grade is given below.
A computer laboratory will accompany some (but not all) lectures.
2. Prerequisites/Audience
Analysis of variance, regression and survival analysis is assumed and general familiarity with clinical trials will be helpful.
3. Textbooks
- Clinical Trials. A methodologic perspective by Steven Piantadosi John Wiley & Sons, New York
- Also, Fundamentals of Clinical Trials, Third Edition by
Introduction
Description of the concept of clinical research; Review of history evolution of the concept of the clinical trials.
Ethics in clinical trials
Concepts of equipoise and uncertainty, conflict between individual and communal rights, Helsinki and other international principles and declarations. The role of the statistician in clinical trials
Randomization
How randomization is done.
Data management systems supporting clinical trials
The critical nature of data management support of clinical trials. The role of the clinical data manager.
Calendar
Announcements
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