LF:DSAM051 Design&analyses of clin.trials - Course Information
DSAM051 Design and analyses of clinical trials
Faculty of Medicineautumn 2023
- 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
- 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)
- Anesthesiology, Intensive Medicine and Pain Management (programme LF, D-ANIM) (2)
- Anesthesiology, Intensive Medicine and Pain Management (programme LF, D-ANIM-A) (2)
- Bioethics (programme LF, D-BIET-A) (2)
- Bioethics (Eng.) (programme LF, D-BET) (2)
- Bioethics (programme LF, D-BET) (2)
- Bioethics (programme LF, D-BIET) (2)
- Biochemistry and Molecular Biology (programme LF, D-BIOM) (2)
- Biochemistry and Molecular Biology (programme LF, D-BIOM_A) (2)
- Cardiology (programme LF, D-VNIT_A) (2)
- Cell and Tissue Morphology (programme LF, D-BIOM_A) (2)
- Dentistry (programme LF, D-STOM_A) (2)
- Dermatovenerology (eng.) (programme LF, D-DE4) (2)
- Dermatovenerology (programme LF, D-DE4) (2)
- Dermatovenerology (programme LF, D-VNIT) (2)
- Dermatovenerology (programme LF, D-VNIT_A) (2)
- Experimental and applied pharmacology (programme LF, D-FARM_A) (2)
- Experimental and applied pharmacology (programme LF, D-FARM) (2)
- Experimental Oncology and Tumor Biology (programme LF, D-ONHE) (2)
- Experimental Oncology and Tumor Biology (programme LF, D-ONHE_A) (2)
- Pharmaceutical medicine (programme LF, D-FARM) (2)
- Physiology and Pathological Physiology (eng.) (programme LF, D-FP4) (2)
- Physiology and Pathological Physiology (programme LF, D-FP4) (2)
- Physiology (programme LF, D-PATFYZ) (2)
- Obstetrics and Gynaecology (eng.) (programme LF, D-GY4) (2)
- Obstetrics and Gynaecology (programme LF, D-GY4) (2)
- Obstetrics and Gynaecology (programme LF, D-CHIR) (2)
- Healthcare Simulation (programme LF, D-SIME-A) (2)
- Hematology (Eng.) (programme LF, D-HEM) (2)
- Hematology (programme LF, D-HEM) (2)
- Hematology (programme LF, D-ONHE) (2)
- Hematology (programme LF, D-ONHE_A) (2)
- Hygiene, Preventive Medicine and Epidemiology (eng.) (programme LF, D-HY4) (2)
- Hygiene, Preventive Medicine and Epidemiology (programme LF, D-HYG) (2)
- Hygiene, Preventive Medicine and Epidemiology (programme LF, D-HY4) (2)
- Hygiene, Preventive Medicine and Epidemiology (programme LF, D-HYG_A) (2)
- Surgery (eng.) (programme LF, D-CI4) (2)
- Surgery (programme LF, D-CI4) (2)
- Surgery (programme LF, D-CHIR) (2)
- Internal Diseases (programme LF, D-VNIT_A) (2)
- Cardiology (programme LF, D-VL4) (2)
- Cardiology (programme LF, D-VNIT) (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 Physics (programme LF, D-ZOBR) (2)
- Medical Chemistry and Biochemistry (eng.) (programme LF, D-LC4) (2)
- Medical Chemistry and Biochemistry (programme LF, D-LC4) (2)
- Medical Chemistry and Biochemistry (programme LF, D-PATFYZ) (2)
- Medical Microbiology and Immunology (eng.) (programme LF, D-MI4) (2)
- Medical Microbiology and Immunology (programme LF, D-MIKRO) (2)
- Medical Microbiology and Immunology (programme LF, D-MI4) (2)
- Medical Chemistry and Biochemistry (programme LF, D-PATFYZ_A) (2)
- Medical Microbiology and Immunology (programme LF, D-MIKRO_A) (2)
- Medical Physics (programme LF, D-ZOBR_A) (2)
- Molecular Medicine (programme LF, D-BIOM_A) (2)
- Molecular medicine (programme LF, D-BIOM) (2)
- Cell and Tissue Morphology (programme LF, D-BIOM) (2)
- Neurology (eng.) (programme LF, D-NR4) (2)
- Neurology (programme LF, D-NEUR) (2)
- Neurology (programme LF, D-NR4) (2)
- Neurology (programme LF, D-NEUR_A) (2)
- Neurosciences (programme LF, D-NEUR_A) (2)
- Neuroscience (eng.) (programme LF, D-NE4) (2)
- Neurosciences (programme LF, D-NEUR) (2)
- Neuroscience (programme LF, D-NE4) (2)
- Obstetrics and Gynaecology (programme LF, D-CHIR_A) (2)
- Ophthalmology (eng.) (programme LF, D-OL4) (2)
- Ophtalmology (programme LF, D-CHIR) (2)
- Ophthalmology (programme LF, D-OL4) (2)
- Oncology (eng.) (programme LF, D-ON4) (2)
- Oncology (programme LF, D-ON4) (2)
- Ophtalmology (programme LF, D-CHIR_A) (2)
- Otorinolaryngology (eng.) (programme LF, D-OR4) (2)
- Otorinolaryngology (programme LF, D-OR4) (2)
- Otorinolarynogology (programme LF, D-STOM) (2)
- Otorinolaryngology (programme LF, D-STOM_A) (2)
- Paediatrics (programme LF, D-PED_A) (2)
- Pathological Physiology (programme LF, D-PATFYZ_A) (2)
- Pathology and Forensic Medicine (programme LF, D-MIKRO_A) (2)
- Pathological Physiology (programme LF, D-PATFYZ) (2)
- Pathology and Forensic Medicine (programme LF, D-MIKRO) (2)
- Pathology (programme LF, D-PA4) (2)
- Paediatrics (eng.) (programme LF, D-PE4) (2)
- Paediatrics (combined) (programme LF, D-PED)
- Paediatrics (programme LF, D-PED)
- Paediatrics (programme LF, D-PE4) (2)
- Pharmaceutical medicine (programme LF, D-FARM_A) (2)
- Physiology (programme LF, D-PATFYZ_A) (2)
- Psychiatry (eng.) (programme LF, D-PC4) (2)
- Psychiatry (programme LF, D-NEUR) (2)
- Psychiatry (programme LF, D-PC4) (2)
- Psychiatry (programme LF, D-NEUR_A) (2)
- Radiology (eng.) (programme LF, D-RA4) (2)
- Radiology (programme LF, D-RA4) (2)
- Radiology (programme LF, D-ZOBR) (2)
- Radiology - Imaging Methods (programme LF, D-ZOBR_A) (2)
- Healthcare Simulation (programme LF, D-SIME) (2)
- Social Medicine (eng.) (programme LF, D-SL4) (2)
- Social Medicine (programme LF, D-SL4) (2)
- Solid Tumors (programme LF, D-ONHE) (2)
- Solid Tumors (programme LF, D-ONHE_A) (2)
- Forensic Medicine (programme LF, D-VL) (2)
- Dentistry (programme LF, D-STOM) (2)
- Dentistry (Eng.) (programme LF, D-ST4) (2)
- Dentistry (programme LF, D-ST4) (2)
- Surgery (programme LF, D-CHIR_A) (2)
- Internal Medicine (eng.) (programme LF, D-VN4) (2)
- Internal Diseases (programme LF, D-VNIT) (2)
- Internal Medicine (programme LF, D-VN4) (2)
- 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 2023 bude probíhat 15., 16. a 17. 1. 2024 (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 2023 bude probíhat 15., 16. a 17. 1. 2024 (pondělí, úterý a středa), všechny dny od 14 do 18 hodin v univerzitním kampusu v Bohunicích. Učebna bude specifikována s předstihem.
- Enrolment Statistics (autumn 2023, recent)
- Permalink: https://is.muni.cz/course/med/autumn2023/DSAM051