LF:BMAM051 Design&analyses of clin.trials - Course Information

BMAM051 Design and analyses of clinical trials

Extent and Intensity

2/0/0. 2 credit(s) (plus extra credits for completion). Type of Completion: k (colloquium).
In-person direct teaching

Teacher(s)

doc. MUDr. Regina Demlová, Ph.D. (lecturer)
RNDr. Tomáš Pavlík, Ph.D. (lecturer)
prof. RNDr. Ladislav Dušek, Ph.D. (lecturer)
PharmDr. Lenka Součková, Ph.D. (lecturer)

Guaranteed by

prof. RNDr. Ladislav Dušek, Ph.D.
Institute of Biostatistics and Analyses – Other Departments for Educational and Scientific Research Activities – Faculty of Medicine
Contact Person: doc. MUDr. Regina Demlová, Ph.D.
Supplier department: Institute of Biostatistics and Analyses – Other Departments for Educational and Scientific Research Activities – Faculty of Medicine

Prerequisites

None, it's a basic course.

Course Enrolment Limitations

The course is offered to students of any study field.

Course objectives

The aim of this course is to introduce the basics of clinical trials design, conduction, analysis and reporting of the study. The course covers legislation aspects, data management issues and all steps of practical experimental design, sample estimation and data analysis.

Learning outcomes

At the end of the course, students are able:
- to understand the basic terminology, ethical and legal aspects of clinical trials,
- to explain key aspects of clinical trial planning and design,
- to describe the key rules for data management in clinical trials,
- to explain differences between the most widely used experimental designs,
- to understand the principles of sample size estimation for a clinical trial,
- to understand the basic methods of clinical trials data analysis,
- to correctly interpret the results of both own and published studies.

Syllabus

• Terminology, ethical and legislation aspects.
• Data management in clinical trials.
• Principles of correct clinical trial course: control group, randomization, blinding.
• Most widely used trial designs.
• Introduction to statistical analysis in clinical trials.
• Examples of hypothesis testing and relationship to experimental design.
• Sample size estimation in clinical trials.
• Analysis of published papers - primary objective, hypothesis, statistical methods, interpretation of results.

Literature

• CHOW, Shein-Chung and Jen-Pei LIU. Design and analysis of clinical trials : concepts and methodologies. Third edition. Hoboken: Willey, 2014, xii, 870. ISBN 9780470887653. info
• FRIEDMAN, Lawrence M., Curt FURBERG and David L. DEMETS. Fundamentals of clinical trials. 4th ed. New York: Springer, 2010, xviii, 445. ISBN 9781441915856. info
• POCOCK, Stuart J. Clinical trials : a practical approach. Chichester: John Wiley & Sons, 1999, xii, 266. ISBN 0471901555. info
• PIANTADOSI, Steven. Clinical trials : a methodologic perspective. New York: John Wiley & Sons, 1997, xxi, 590. ISBN 0471163937. info

Teaching methods

Presentations in Microsoft Teams with real data examples and students involvement.

Assessment methods

One written test focused on principles of clinical trials methodology and basics of data analysis. Students involvement during the course is also required.

Language of instruction

Czech

Further comments (probably available only in Czech)

The course is taught annually.
The course is taught: in blocks.
Note related to how often the course is taught: Výuka pro podzimní semestr 2024 bude probíhat 13., 14. a 15. 1. 2025 (pondělí, úterý a středa), všechny dny od 14 do 18 hodin v univerzitním kampusu v Bohunicích. Učebna bude specifikována s předstihem.
Information on the extent and intensity of the course: Výuka pro podzimní semestr 2024 bude probíhat 13., 14. a 15. 1. 2025 (pondělí, úterý a středa), všechny dny od 14 do 18 hodin v univerzitním kampusu v Bohunicích. Učebna bude specifikována s předstihem.

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