Organization of scientific activity

Course annotation

Organization of scientific activity (3 European Credits)

Taught by: Prof. Vasily Fokin, assoc. prof. Tatiana Rudenko

Students are introduced to the basic concepts of research in biomedicine. The ultimate goal of the course is the development of the skills in organization and planning of scientific research and analysis of the results of biomedical research. Information about the principles of evidence-based medicine and good clinical practice is provided, as it is necessary to evaluate the quality of medical technologies, successful publication and commercialization of research in biomedicine.

The module covers the following topics:

·   Organization of scientific activity: achievements, problems, technology.

·   Prospects for scientific activities.

·   Planning stages of clinical research.

·   Evaluation and quality control of medical technologies.

·   Analysis of publications on assessing the effectiveness of medical interventions.

Learning objectives:

As a result of the course, a student must:

·   know: stages of organization of scientific activity, technology of organization,  stages of research in biomedicine; the specifics of the main types of clinical trials; Principles of good practice research;

·   be able to: assess the quality of biomedical research planning; analyze the results of publications to assess the effectiveness of medical interventions;

·   master: skills of planning studies to ensure maximum effectiveness of their.

Content of the module:

Ethics of medical research. International standard GCP. Principles for the conduct of clinical trials. Classification of clinical research. Compliance with design and research problems. Surrogate and true outcome assessment. Randomized controlled trials - standard of quality of medical research. The levels and scales of quality evaluation of evidence. Classification of violations of the principles of good practice research. Error statistical conclusion. Errors specific to the medical research. Scientific publications as a source of information. The general algorithm analysis of scientific medical publications.

Overview of tasks and lectures:

7 two-hour lectures, 5 practical classes of 2 hours each and project works totaling 12 hours in the third semester.

Topics of lectures:

1. Organization of scientific activity: achievements, problems.
2. Technology of organization of scientific activity.
3. Prospects for scientific activities.
4. Medical research ethics. Standards of clinical practice.
5. Kinds of clinical trials.
6. Common Errors of statistical analysis of biomedical data.
7. Evaluation and quality inspection of medical technologies.

Practical classes on topics:

·   Planning of scientific activity.

·   Technology of scientific activity.

·   Planning for medical research.

·   Evaluation of the effect of health care interventions.

·   Analysis of scientific and medical publications.

Position within the programme

This is a unique module providing knowledge about stages of organization of scientific activity and stages of research in biomedicine and also the specifics of the main types of clinical trials. Principles of good practice research are also discussed. The acquired knowledge and skills are relevant to assess the quality of biomedical research.

Teaching format

Structure

The module is scheduled for the third semesters. The course involves 108 hours, including 36 hours in the classroom. The sections of the course are given 12 weeks (7 lessons of 2 hours, 5 practical classes of 2 hours each and project works totaling 12 hours. Lectures are given in a videoconference auditorium and e-learning technology is used for individual work.

Grading

The form of final assessment is a credit test (pass/fail examination). The exam requires satisfactory performance in individual practical studies and participation in discussion of the seminar topics.