LF:DSAM051 Design&analyses of clin.trials - Course Information

DSAM051 Design and analyses of clinical trials

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)

Guaranteed by

prof. RNDr. Ladislav Dušek, Ph.D.
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

• Anatomy, Histology and Embryology (eng.) (programme LF, D-AN4) (2)
• Anatomy, Histology and Embryology (programme LF, D-AN4) (2)
• Anesthesiology, Intensive Medicine and Pain Management (eng.) (programme LF, D-AL4) (2)
• Anesthesiology, Intensive Medicine and Pain Management (programme LF, D-AL4) (2)
• Dermatovenerology (eng.) (programme LF, D-DE4) (2)
• Dermatovenerology (programme LF, D-DE4) (2)
• Physiology and Pathological Physiology (eng.) (programme LF, D-FP4) (2)
• Physiology and Pathological Physiology (programme LF, D-FP4) (2)
• Obstetrics and Gynaecology (eng.) (programme LF, D-GY4) (2)
• Obstetrics and Gynaecology (programme LF, D-GY4) (2)
• Hygiene, Preventive Medicine and Epidemiology (eng.) (programme LF, D-HY4) (2)
• Hygiene, Preventive Medicine and Epidemiology (programme LF, D-HY4) (2)
• Surgery (eng.) (programme LF, D-CI4) (2)
• Surgery (programme LF, D-CI4) (2)
• Cardiology (programme LF, D-VL4) (2)
• Medical Biophysics (eng.) (programme LF, D-BF4) (2)
• Medical Biophysics (programme LF, D-BF4) (2)
• Medical Biology (eng.) (programme LF, D-LB4) (2)
• Medical Biology (programme LF, D-LB4) (2)
• Medical Pharmacology (eng.) (programme LF, D-FA4) (2)
• Medical Pharmacology (programme LF, D-FA4) (2)
• Medical Chemistry and Biochemistry (eng.) (programme LF, D-LC4) (2)
• Medical Chemistry and Biochemistry (programme LF, D-LC4) (2)
• Medical Microbiology and Immunology (eng.) (programme LF, D-MI4) (2)
• Medical Microbiology and Immunology (programme LF, D-MI4) (2)
• Neurology (eng.) (programme LF, D-NR4) (2)
• Neurology (programme LF, D-NR4) (2)
• Neuroscience (eng.) (programme LF, D-NE4) (2)
• Neuroscience (programme LF, D-NE4) (2)
• Ophthalmology (eng.) (programme LF, D-OL4) (2)
• Ophthalmology (programme LF, D-OL4) (2)
• Oncology (eng.) (programme LF, D-ON4) (2)
• Oncology (programme LF, D-ON4) (2)
• Otorinolaryngology (eng.) (programme LF, D-OR4) (2)
• Otorinolaryngology (programme LF, D-OR4) (2)
• Pathology (programme LF, D-PA4) (2)
• Paediatrics (eng.) (programme LF, D-PE4) (2)
• Paediatrics (programme LF, D-PE4) (2)
• Psychiatry (eng.) (programme LF, D-PC4) (2)
• Psychiatry (programme LF, D-PC4) (2)
• Radiology (eng.) (programme LF, D-RA4) (2)
• Radiology (programme LF, D-RA4) (2)
• Social Medicine (eng.) (programme LF, D-SL4) (2)
• Social Medicine (programme LF, D-SL4) (2)
• Forensic Medicine (programme LF, D-VL) (2)
• Dentistry (Eng.) (programme LF, D-ST4) (2)
• Dentistry (programme LF, D-ST4) (2)
• Internal Medicine (eng.) (programme LF, D-VN4) (2)
• Internal Medicine (programme LF, D-VN4) (2)

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

• Wooding, W.M. (1994) Planning pharmaceutical clinical trials. John Wiley and Sons. 529 pp.
• Meinert, C. L. Clinical Trials (1996) Design, Conduct and Analysis. Oxford University Press.. 469 pp.
• Piantadosi, S. (1986) Clinical Trials A Methodological Perspective. John Wiley and Sons. 469 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.
• 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.
• McFaccen, E. (1998) Management of Data in Clinical Trials. John Wiley and Sons. 210 pp.

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 each semester.
The course is taught: in blocks.
Note related to how often the course is taught: 30.5-1.6.2011.
Information on the extent and intensity of the course: 30.5-1.6.2011.

• Enrolment Statistics (Spring 2011, recent)
  
• Permalink: https://is.muni.cz/course/med/spring2011/DSAM051