Clinical Trials I (SL_107)
About Study Course
Objective
Clinical trials, as opposed to epidemiological studies, are prospectively planned experiments to obtain data-based evidence regarding the efficacy and/or safety of one or several treatments. The aim of this course, which is one of two courses on design and analysis of clinical trials, is twofold:
(i) to explain the concept of a clinical trial and account for the main ingredients of such trials;
(ii) to explain and explore the main statistical concepts and methods used in the design and analysis of clinical trials.
The emphasis is on how such methods can be used in practice especially in connection to convenient software packages.
Prerequisites
To follow this course, the student is required to be familiar with basic mathematical and statistical concepts, as well as have computer skills.
Learning outcomes
After the course students will:
• Show understanding of concepts related to clinical trials.
• Demonstrate knowledge of basic statistical methods for clinical trials.
• Know designs for clinical trials and randomization.
• Explain and illustrate classification of clinical trials, cancer trials.
• Expanding knowledge of continuous data, non-continuous data, longitudinal data, survival data.
• Know multiplicity and sample size determination.
After having completed this course, the student will be able to use theory and methods for the most common types of clinical trials and their rationale including blinding, randomization and sample size calculation. The student is also supposed to master the most common statistical techniques for analysing data from trials and to perform appropriate statistical analyses for various design types covered in the course using software packages.
After having completed this course the student is supposed to be competent to:
• handle independently the design;
• propose a theoretical design of a Randomized Controlled Trial (RCT) according to certain specifications;
• plan various aspects of an RCT such as endpoints, comparators, sample size, randomization etc.;
• evaluate various alternative designs and to introduce both specialists in the field and non-specialists;
• professionally handle the analysis of the most common types of clinical trials, including blinding, randomization and sample size calculation.
Moreover, the student will master the most used statistical techniques for analysing such trials, including data analysis of clinical trials using adequate method accordingly to guidelines as well as implementing innovative statistical approaches to research.
Study course planning
| Study programme | Study semester | Program level | Study course category | Lecturers | Schedule |
|---|---|---|---|---|---|
| Biostatistics, MFBS | 1 | Master’s | Required |
