DSAM051 Design and analyses of clinical trials

Faculty of Medicine
autumn 2022
Extent and Intensity
2/0/0. 5 credit(s). Type of Completion: zk (examination).
Teacher(s)
PharmDr. Lenka Součková, Ph.D. (lecturer)
RNDr. Tomáš Pavlík, Ph.D. (lecturer)
doc. MUDr. Regina Demlová, Ph.D. (lecturer)
Renata Bláblová (assistant), Renata Bláblová (deputy)
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 also offered to the students of the fields other than those 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
  • PIANTADOSI, Steven. Clinical trials : a methodologic perspective. New York: John Wiley & Sons, 1997, xxi, 590. ISBN 0471163937. info
  • POCOCK, Stuart J. Clinical trials : a practical approach. Chichester: John Wiley & Sons, 1999, xii, 266. ISBN 0471901555. 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)
Study Materials
The course is taught annually.
The course is taught: in blocks.
Note related to how often the course is taught: Výuka pro podzimní semestr 2022 bude probíhat 16., 17. a 18. 1. 2023 (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 2022 bude probíhat 16., 17. a 18. 1. 2023 (pondělí, úterý a středa), všechny dny od 14 do 18 hodin v univerzitním kampusu v Bohunicích. Učebna bude specifikována s předstihem.
The course is also listed under the following terms Spring 2000, Autumn 2000, Autumn 2001, Autumn 2002, Autumn 2003, Autumn 2004, Autumn 2005, Spring 2006, Autumn 2006, Spring 2007, Autumn 2007, Spring 2008, Autumn 2008, Spring 2009, Autumn 2009, Spring 2010, Autumn 2010, Spring 2011, Autumn 2011, Spring 2012, Autumn 2012, Spring 2013, Autumn 2013, Spring 2014, Autumn 2014, Spring 2015, Autumn 2015, Spring 2016, Autumn 2016, Spring 2017, Autumn 2017, Spring 2018, autumn 2018, spring 2019, autumn 2019, spring 2020, autumn 2020, spring 2021, autumn 2021, spring 2022, spring 2023, autumn 2023, spring 2024, autumn 2024, spring 2025.
  • Enrolment Statistics (autumn 2022, recent)
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