BMAM051 Design and analyses of clinical trials

Faculty of Medicine
Autumn 2005
Extent and Intensity
2/0/0. 2 credit(s) (plus 1 credit for an exam). Type of Completion: zk (examination).
Teacher(s)
Mgr. Adam Svobodník, Ph.D. (lecturer)
doc. MUDr. Oldřich Coufal, Ph.D. (lecturer)
RNDr. Jan Mužík, Ph.D. (assistant)
RNDr. Eva Gelnarová (assistant)
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: Mgr. Adam Svobodník, Ph.D.
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
DAY 1: Terminology, ethical and legislative aspects
1. Terminology: Clinical trial. Phase I-IV studies. Principal investigator. Investigator. Monitor. Biostatistician. Trial subjects. Contract research organisation (CRO). Study protocol. Case report form (CRF). Good clinical practice (ICH GCP).
2. Management of clinical trials: Communication with regulatory authorities (SÚKL), documentation. Insurance of clinical trial. Application of approval of clinical trial, protocol amendments, annual report, early termination, clinical study reports.
3. Ethical aspects: Informed consent, Declaration of Helsinki.
4. Legal aspects: Legislative norms in Czech Republic and European community, harmonisation.
DAY 2: Analyses of clinical trials
1. Study design: Parallel design. Cross-over and factorial design. Phase I-IV studies.
2. Data analyses: Minimum of biostatistics: Types of data in clinical trials. Presentation of data (descriptive statistics). Hypotheses testing.
3. Sample size estimation: Factors limiting sample size. Fundamental equations. Software tools.
4. Randomization: Fundamentals of randomization, randomness. Complete randomizastion. Permuted block randomization. Stratification. Adaptive randomisation design.
5. Applied data analysis in clinical trials Study protocol. Data management. Structure of study reports.
Syllabus
  • DAY 1: Terminology, ethical and legislative aspects
  • 1. Terminology: Clinical trial. Phase I-IV studies. Principal investigator. Investigator. Monitor. Biostatistician. Trial subjects. Contract research organisation (CRO). Study protocol. Case report form (CRF). Good clinical practice (ICH GCP).
  • 2. Management of clinical trials: Communication with regulatory authorities (SÚKL), documentation. Insurance of clinical trial. Application of approval of clinical trial, protocol amendments, annual report, early termination, clinical study reports.
  • 3. Ethical aspects: Informed consent, Declaration of Helsinki.
  • 4. Legal aspects: Legislative norms in Czech Republic and European community, harmonisation.
  • DAY 2: Analyses of clinical trials
  • 1. Study design: Parallel design. Cross-over and factorial design. Phase I-IV studies.
  • 2. Data analyses: Minimum of biostatistics: Types of data in clinical trials. Presentation of data (descriptive statistics). Hypotheses testing.
  • 3. Sample size estimation: Factors limiting sample size. Fundamental equations. Software tools.
  • 4. Randomization: Fundamentals of randomization, randomness. Complete randomizastion. Permuted block randomization. Stratification. Adaptive randomisation design.
  • 5. Applied data analysis in clinical trials Study protocol. Data management. Structure of study reports.
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 (26.-27.11.2003).
Information on the extent and intensity of the course: 2 dny - 2 bloky (26.-27.11.2003).
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 2002, Autumn 2003, Autumn 2004, 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 2005, recent)
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