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
1.After the course, students:
• demonstrate understanding of concepts related to clinical trials;
• will be familiar with the types of clinical trials and randomisations;
• explain and illustrate the classification of clinical trials;
• will be familiar with multiplicity and sampling.
1.After completing the course, the student will be able to independently use theory and methods about the most common types of clinical trials and to perform logical reasoning, masking, randomization and sample volume calculation by preparing a research minutes.
1.After completing this course, the student will be competent:
• establish a study plan on a continuous basis;
• propose innovative approaches to the study plan in accordance with certain specifications;
• plan different aspects of clinical research, such as target parameters, comparators, sample size, randomization, etc.;
• evaluate different alternative plans and present them to both specialists and non-specialists in the field;
• perform professional analysis of the most common types of clinical trials, including masking, randomisation, and sampling.
In addition, the student will understand aspects of good clinical practice and legislation.
Study course planning
| Study programme | Study semester | Program level | Study course category | Lecturers | Schedule |
|---|---|---|---|---|---|
| Biostatistics | 1 | Master's | Required | Agita Melbārde-Kelmere, Guna Dansone, Andrejs Ivanovs, Jana Migliniece | |
| Biostatistics | 1 | Master's | Required | Agita Melbārde-Kelmere, Guna Dansone, Andrejs Ivanovs, Jana Migliniece |
