DSAM051 Design and analyses of clinical trials

Faculty of Medicine
Autumn 2015
Extent and Intensity
2/0/0. 5 credit(s). Type of Completion: zk (examination).
Teacher(s)
doc. MUDr. Regina Demlová, Ph.D. (lecturer)
RNDr. Tomáš Pavlík, 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
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
Main objective of this course is to introduce the basics of clinical trials assessment. The course covers legislation aspects, data management issues and all steps of practical experimental design and data analysis.
Syllabus
  • PART 1: Terminology, ethical and legislation aspects 1. Elementary terms: Clinical trials, their conduct and assessment. Phase I-IV. Monitoring. Statistician. Test Subjects. Clinical Research Organization (CRO). Clinical Trial Protocol. CRF. ICH GCP. 2. Clinical Trial Organization: Communication with regulatory authorities, documentation. Clinical Trial Insurance. Reporting. 3. Ethical aspects: Informed consent. Declaration of Helsinki. 4. Legislation aspects: Main legislation sources in the Czech Republic and E.U., harmonization. PART 2: Data Analysis: Experimental Design, Data Management and Evaluation of Results. 1. Principles of Correct Clinical Trial Course. Control Group. Randomization. Blinding. Sample Size Estimation. 2. Experimental Design: Parallel Design. Cross-over and Factorial Designs. Design According to Study Phase I-IV. 3. Introduction to Statistical Analysis: Types of Data. Vizualizaion and Summary Statistics. Principles of Hypotheses Testing. Relationship of Experimental Design and Statistical Techniques. 4. Sample Size Estimation: Factors Influencing Sample Size Determination. Principles and Practical Examples. Software Tools. 5. Randomization: Role of Randomization, Randomness. Complete Randomization. Permutation Block Randomization. Stratification. Adaptive Randomization Techniques. 6. Applied Data Analysis. Analysis of Published Papers - Primary Objective, Hypothesis, Statistical Methods, Interpretation of Results.
Literature
  • Piantadosi, S. (1986) Clinical Trials A Methodological Perspective. John Wiley and Sons. 469 pp.
  • McFaccen, E. (1998) Management of Data in Clinical Trials. John Wiley and Sons. 210 pp.
  • Meinert, C. L. Clinical Trials (1996) Design, Conduct and Analysis. Oxford University Press.. 469 pp.
  • Cleophas, T., J. et al. (2000) Statistics Applied to Clinical Trials. Kluwer Academic Publishers. 97 pp.
  • Norleans, M. X. (2001) Statistical methods for clinical trials. Marcel Dekker. 257 pp.
  • Wooding, W.M. (1994) Planning pharmaceutical clinical trials. John Wiley and Sons. 529 pp.
  • Liu, J.-Chow, S. (1998) Design and Analysis of Clinical Trials: Concepts and Methodologies. John Wiley and Sons. 648 pp.
  • Machin, D. et al. (1987) Sample size tables for clinical studies. Blackwell Science. 315 pp.
Teaching methods
Theoretical lectures with real examples
Assessment methods
The course is evaluated via written exam focused on principles and basics of data analysis for clinical trials assessment.
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: 11.-12. 1. 2016 ve 14 - 18 hodin v učebně IBA1, Kotlářská 2.
Information on the extent and intensity of the course: 11.-12. 1. 2016 ve 14 - 18 hodin v učebně IBA1, Kotlářská 2.
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, 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, autumn 2022, spring 2023, autumn 2023, spring 2024, autumn 2024, spring 2025.
  • Enrolment Statistics (Autumn 2015, recent)
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