Statistical Methods in the Analysis of Clinical Studies
Code  Completion  Credits  Range  Language 

F7PMS1BSCD  Z,ZK  5  1P+3S  Czech 
 Course guarantor:
 Lecturer:
 Tutor:
 Supervisor:
 Department of Biomedical Technology
 Synopsis:

The subject is focused on methods of statistical analysis intended primarily for medical research and the needs of clinical evaluation of medical devices. Within the subject, students will become familiar with the methodology of clinical research, the design of clinical studies, and subsequently with commonly used methods of processing and testing clinical data.
 Requirements:

Credit conditions: Mandatory participation in seminars (max. 2 absences). The student is obliged to prepare for the seminar in advance, prepare the assigned independent work and successfully write the entrance test at the beginning of the lesson; failure to meet these conditions may lead to the exclusion of the student from the given seminar and is considered an absence. The student is required to pass the credit test with at least 50%.
Exam requirements: The exam is oral, where the student chooses a random selection of questions covering the topics of the lectures. In order to be admitted to the oral exam, the student must meet the credit requirements and write at least 50% practice test consisting of numerical examples.
 Syllabus of lectures:

• Statistical methodology, population and selection, basic design of clinical trials.
• Random variable, basic probability distribution.
• Evaluation of clinical studies: descriptive statistics, confidence intervals.
• Evaluation of clinical studies: statistical testing – parametric tests, nonparametric tests.
• Evaluation of clinical studies: statistical testing  qualitative variables, testing of contingency tables.
• Correlation and regression in biomedical research.
 Syllabus of tutorials:

• Clinical trial design – data measurement for a data set.
• Basics of working with statistical software I.
• Basics of working with statistical software II.
• Probability, a random variable with a normal distribution.
• Creation of descriptive statistics and graphic presentation of data.
• Confidence intervals and their use in descriptive and inductive statistics.
• Statistical testing – parametric tests I.
• Statistical testing – parametric tests II.
• Statistical testing – nonparametric tests.
• Statistical testing – qualitative variables.
• Statistical testing – pivot tables.
• Survival analysis – probability of survival, KaplanMeier survival analysis.
 Study Objective:
 Study materials:

[1] HENDL, Jan. Qualitative research: basic theory, methods and applications. 3rd ed. Prague: Portal, 2012. ISBN 9788026202196
[2] OTIPKA, Petr and Vladislav ŠMAJSTRLA. Probability and Statistics. Ostrava: Vysoká škola baňská  Technical University, 2006. ISBN 8024811944. (Freely available at: http://homen.vsb.cz/~oti73/cdpast1/)
[3] SOCR. The Probability and Statistics EBook. Los Angeles: Statistics Online Computational Resource. 2014. (Freely available at: http://wiki.stat.ucla.edu/socr/index.php/EBook)
Study aids
Supports intended for the combined form of study and presentation published on the website of the subject.
 Note:
 Further information:
 No timetable has been prepared for this course
 The course is a part of the following study plans:

 Systematic Integration of Prosesses of Healthcare (compulsory course)