Veidlapa Nr. M-3 (8)
Study Course Description
Clinical Research and Analysis
Course Code
FFK_019
Branch of Science
Basic medicine; Social Pharmacy
ECTS
4.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Elita Poplavska
Structure Unit Manager
Inga Urtāne
Structural Unit
Department of Pharmacology and Pharmacotherapy
Contacts
Riga, Konsula street 21, lfk@rsu.lv
About Study Course
Objective
1. To introduce the scientific, statistical and ethical principles of medical research. 2. To learn the basic principles of clinical trial design. 3. To learn the basic principles of statistical calculations in clinical trials. 4. To develop skills in interpreting and critically evaluating the results of clinical trial publications.
Preliminary Knowledge
Informatics, mathematics
Learning Outcomes
Knowledge
1.On completion of this course, students will: 1. describe the types and designs of different medical research studies 2. know the levels of evidence and the differences between them 3. know the basic principles of experimental research design 4. define the requirements for assessing the efficacy and safety of medicines 5. be familiar with the criteria for analysing clinical trial publications 6. know the basic principles of descriptive and inferential statistics in clinical trials 7. identify ethical principles in clinical trials and their importance 8. know the basic principles of systematic review methodology.
Skills
1.On completion of this course, students will: 1. be able to define key words and search for clinical trial and systematic review protocols and publications 3. be able to distinguish between levels of evidence 4. be able to assess the methodological quality of clinical trials 5. be able to evaluate statistical results of clinical trials 6. be able to assess the clinical/practical relevance of the results of clinical trials 7. be able to assess the methodological quality of systematic reviews 8. be able to assess the results of systematic reviews.
Competences
1.On completion of this course, students will: 1. be able to critically evaluate the methodological quality of clinical research; interpret its impact on the reliability of results 2. be able to interpret the statistical results of clinical trials; their applicability to practice in the context of the methodological quality and other similar trials; justify their opinions.
Assessment
Individual work
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Title
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% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Reading assignments, analysis of a movie, reading and analysis of research publications, group work.
In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
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Examination
|
Title
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% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
10 points
|
|
For full-time students: he final grade in the first semester consists of 90% group and individual work (class attendance and tests) and 10% mid-term grades. Students will be eligible for the placement if they achieve at least 55% of the maximum marks for the semester. The final grade in this course is based on the marks obtained in the first and second semesters: 50% group and individual work (class attendance, tests and group work) and 50% marks obtained in the written examination. Students will be eligible for the examination if they achieve at least 55% of the maximum marks in each of the assessment units in the second semester. The final grade will be composed of the points obtained in both the first and second semesters. |
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Study Course Theme Plan
FULL-TIME
Part 1
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Observational and descriptive studies.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Basic principles of experimental research studies
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Types of clinical study design, the levels of evidence.
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Basic principles of evidence-based information search.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
How to read a scientific paper?
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Basic principles of evidence-based information search. PICO formulation.
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Basic statistical principles for clinical trials
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Design of experimental studies. Evaluating the efficacy and safety of medicines.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Basic principles of experimental research studies
|
Total ECTS (Creditpoints):
2.00
Contact hours:
23 Academic Hours
Final Examination:
Test (Semester)
Part 2
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Basic principles of descriptive and inferential statistics. Interpretation of results.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Non-inferiority studies and bioequivalence studies.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Ethics of clinical trials
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Systematic reviews and meta-analyses, their assessment.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Basic principles of descriptive and inferential statistics. Interpretation of results.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Efficacy and effectiveness of medicines
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Systematic reviews and meta-analyses, their assessment.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Primary and secondary endpoints.
|
Total ECTS (Creditpoints):
2.00
Contact hours:
24 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
Kokreina apvienības veidotie sistemātiskie pārskatiSuitable for English stream
2.
Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials. Springer, 2015.Suitable for English stream
3.
Greenhalgh, T.How to read a paper. BMJ Books, 2014. p.238Suitable for English stream
4.
US National Library of Medicine National Institutes of Health datubāzesSuitable for English stream
Additional Reading
1.
Brody, T. Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Burlington: Academic Press, 2016.Suitable for English stream
2.
Hammond, Flora Malec, James F. Nick, Todd Buschbacher, Ralph M. Handbook for Clinical Research : Design, Statistics, and Implementation. New York, NY: Demos Medical, 2015.Suitable for English stream
3.
Harris, M., Taylor. G. Medical Statistics Made Easy. 2021
4.
Hulley, Stephen B. Cummings, Steven R. Browner, Warren S. Grady, Deborah Newman, Thomas B. Designing Clinical Research. Fourth edition. Philadelphia: LWW, 2013.
5.
Balakrishnan, N. Methods and Applications of Statistics in Clinical Trials Volume 1, Principles, Trials, and Designs Concepts, Principles, Trials, and Designs. Wiley. 2014.Suitable for English stream
6.
Machin, D., & Fayers, P. Randomized Clinical Trials : Design, Practice and Reporting. Chichester: John Wiley & Sons. 2010.
7.
Brody, Tom. Clinical Trials. San Diego: Elsevier Science & Technology. 2016.Suitable for English stream