MZKPL0311s Planning, organization and evaluation of clinical studies - p

Faculty of Medicine
autumn 2023
Extent and Intensity
0/1/0. 2 credit(s). Type of Completion: z (credit).
Teacher(s)
RNDr. Tomáš Pavlík, Ph.D. (seminar tutor)
Mgr. Tereza Friessová (assistant)
Mgr. Bc. Alena Langaufová, Ph.D. (assistant)
Guaranteed by
RNDr. Tomáš Pavlík, Ph.D.
Institute of Biostatistics and Analyses – Other Departments for Educational and Scientific Research Activities – Faculty of Medicine
Contact Person: Mgr. Bc. Alena Langaufová, Ph.D.
Supplier department: Institute of Biostatistics and Analyses – Other Departments for Educational and Scientific Research Activities – Faculty of Medicine
Timetable
Fri 13. 10. 13:30–16:00 F01B1/709, 16:00–17:40 F01B1/709
Prerequisites
None, it's a basic course.
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.
fields of study / plans the course is directly associated with
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
seminar
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)
Study Materials
Information on the extent and intensity of the course: 5.
The course is also listed under the following terms autumn 2024.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/med/autumn2023/MZKPL0311s