BMAM051 Data management and analyses of Clinical Trials

Faculty of Medicine
Autumn 2002
Extent and Intensity
2/0/0. Type of Completion: zk (examination).
Teacher(s)
Mgr. Adam Svobodník, Ph.D. (lecturer)
RNDr. Jan Mužík, Ph.D. (assistant)
Guaranteed by
prof. RNDr. Ladislav Dušek, Ph.D.
Centre for Biostatistics and Analyses – Specialized Units – Faculty of Medicine
Contact Person: Mgr. Adam Svobodník, Ph.D.
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
Basic terminology. Types of clinical trials. Statistics in clinical trials: Basic concepts. Types of data in clinical trials. Hypotheses testing. Effectiveness evaluation. Safety evaluation. Trial Protocol. Design of clinical trial. Parametric evaluation of drug effectiveness and safety. CRF. Sample size optimization. Randomization. Interim analysis. Final report. Interpretation of trial results. Publication of trial results. Sub-group analysis. Post-Hoc analysis. Analysis of prognostic factors. Metaanalysis. Bioequivalence studies. Data management in clinical trials. Guidelines and regulations. Good clinical practice. QA/QC. Electronic CRF. Central database. Data entry. Data transfer. Multicentric trials.
Syllabus
  • Basic statistical terminology in clinical trials. Types of clinical trials: Phase I-IV trials, pilot studies, postmarketing research, bioequivalence studies. Statistics in clinical trials: Basic concepts, trial protocol, CRF, randomization, interim analysis, final report. Types of data in clinical trials: continuous variables, categorical variables, survival data. Hypotheses testing: Investigator's and statistical hypothesis, primary and secondary trial objectives. Effectiveness evaluation: Intention-to-treat and per-protocol analysis. Safety evaluation: analyses of adverse events, abnormal laboratory data. Trial Protocol: statistical part of trial protocol. Design of clinical trial: blindness, randomization, evaluation timing. Parametric evaluation of drug effectiveness and safety. CRF. Sample size optimization: methodology. Randomization: stratification, permutation, adaptive algorithms. Interim analysis. Final report. Interpretation of trial results. Publication of trial results. Sub-group analysis. Post-Hoc analysis. Analysis of prognostic factors. Metaanalysis. Bioequivalence studies: methodology. Data management in clinical trials. Guidelines and regulations. Good clinical practice. QA/QC. Electronic CRF. Central database. Data entry. Data transfer. Multicentric trials.
Literature
  • Cleophas, T., J. et al. Statistics Applied to Clinical Trials. Kluwer Academic Publishers. 2000. 97 pp.
  • Liu, J.-Chow, S. Design and Analysis of Clinical Trials: Concepts and Methodologies. John Wiley and Sons. 1998. 648 pp.
  • Machin, D. et al. Sample size tables for clinical studies. Blackwell Science. 1987. 315 pp.
  • McFaccen, E. Management of Data in Clinical Trials. John Wiley and Sons. 1998. 210 pp.
  • Meinert, C. L. Clinical Trials: Design, Conduct and Analysis. Oxford University Press. 1996. 469 pp.
  • Norleans, M. X. Statistical methods for clinical trials. Marcel Dekker. 2001. 257 pp.
  • Piantadosi, S. Clinical Trials: A Methodological Perspective. John Wiley and Sons. 1986. 469 pp.
  • Shuster, J., J. Handbook of sample size guidelines for clinical trials. CRC Press. 1990. 854 pp.
  • Wooding, W., M. Planning pharmaceutical clinical trials. John Wiley and Sons. 1994. 529 pp.
Language of instruction
Czech
Further comments (probably available only in Czech)
The course is taught annually.
The course is taught: every week.
Note related to how often the course is taught: dle potřeby možno i blokově.
Teacher's information
http://www.cba.muni.cz/vyuka/
The course is also listed under the following terms Spring 2000, Autumn 2000, Autumn 2001, Autumn 2003, Autumn 2004, Autumn 2005, Autumn 2006, Autumn 2007, Autumn 2008, Autumn 2009, Autumn 2010, Autumn 2011, Autumn 2012, Autumn 2013, Autumn 2014, Autumn 2015, Autumn 2016, Autumn 2017, autumn 2018, autumn 2019, autumn 2020, autumn 2021, autumn 2022, autumn 2023, autumn 2024.
  • Enrolment Statistics (Autumn 2002, recent)
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