Veidlapa Nr. M-3 (8)
Study Course Description
Clinical Research
Course Code
ZFTK_048
Branch of Science
-
ECTS
4.50
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Elita Poplavska
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 16 Dzirciema Street, zftk@rsu.lv, +371 67061547
About Study Course
Objective
1. Introduce students to the main scientific, statistical and ethical principles of clinical research.
2. Learn the principles of evidence-based information search. Learn how to evaluate quality and reliability of evidence.
3. Learn how to critically appraise scientific publications.
4. Introduce students with all the scientific, statistical and ethical principles of medical research.
5. Introduce with research organization and the role of a pharmacist in research.
Preliminary Knowledge
Informatics, mathematics
Learning Outcomes
Knowledge
1.Upon completion of this course, students will: 1. describe different types of research studies; 2. know advantages and applications of various research methods; 3. know criteria for critical appraisal of publications; 4. identify ethical principles of research and their significance.
Skills
1.Upon completion of the study course, students will be able to: 1. use the available evidence-based databases and other resources to search for studies, systematic reviews, meta-analysis; 2. develop tailored information retrieval strategy and find necessary information; 3. differentiate various research designs; 4. evaluate the adequacy of the method to the research questions; 5. evaluate quality of research methods; 6. evaluate the methods of statistical analysis, the power of statistical proof; 7. interpret results of statistical and clinical significance; 8. write a critical review of a publication; 9. identify and evaluate ethical issues in clinical studies; 10. evaluate quality of systematic reviews and meta-analysis, and interpret the results.
Competences
1.Upon completion of this course, students will be able to: 1. find research studies and systematic reviews and critically appraise them; 2. evaluate applicability of the study results to patient care; 3. make ethical decisions in research setting.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Reading assignments, analysis of a movie, reading and analysis of research publications, writing a research protocol, creating presentations.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
For full-time students:
The final grade in the first semester consists of: 100% group and individual work (attendance of lectures and classes, presentation, group test results). The student will be credited if they receive at least 55% of the maximum points in the first semester.
In the second semester:
The final grade in this subject and in the second semester consists of: 30% group and individual work (tests, lecture attendance, team member assessment, presentations, randomized controlled trial analysis) and 70% end-of-course written exam. Students will be eligible for the exam if they obtain at least 55% of the maximum score in each of the assessment units in the second semester.
For part-time students:
The final grade in the first semester consists of: 100% group and individual work (attendance of lectures and classes, presentation, group test results). The student will be credited if they receive at least 55% of the maximum points in the first semester.
The final grade in this subject and in the second semester consists of: Final exam result. Access to the exam can be obtained by gaining a successful grade in the tests, attending all lectures and classes, developing presentations, and successfully conducting a randomized controlled trial analysis.
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Introduction. Basic principles of evidence-based information search and citation formation principles.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Types of clinical study design, the levels of evidence.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Pharmaceutical information. Basic principles of electronic information search. Basic principles of citation formation.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Basic principles of electronic information search. Finding the evidence: searching principles and study analysis. Evidence-based medical databases, their use.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Types of study in medical research – observational studies. Principles of evidence based health care. Levels of evidence.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Types of study in medical research – experimental studies. Principles of evidence based health care. Levels of evidence.
|
Total ECTS (Creditpoints):
1.50
Contact hours:
16 Academic Hours
Final Examination:
Test (Semester)
Part 2
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Research planning. Study outcomes.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Ethics in research. Statistical calculation, interpretation of the study results.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Organisation and supervision of clinical trials. Clinical research organisations.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Planning research. Methods for randomization and blinding.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Phase I research studies.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Phase II and III research studies. Study designs.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Primary and secondary research endpoints.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Research ethics.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Basic principles of descriptive and inferential statistics. Interpretation of results.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Basic principles of descriptive and inferential statistics. Interpretation of results.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pragmatic trials. Monitoring of adverse events.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Non-inferiority studies.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Bioequivalence and equivalence studies.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Systematic reviews and meta-analyses, their assessment.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Systematic reviews and meta-analyses, their assessment.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Systematic reviews and meta-analyses, their assessment.
|
Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
Kokreina apvienības veidotie sistemātiskie pārskati
2.
Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials.Springer, 2010.
3.
Greenhalgh, T.How to read a paper. BMJ Books, 2010. p.238
4.
US National Library of Medicine National Institutes of Health datubāzes
Additional Reading
1.
Brody, T. Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Burlington: Academic Press, 2011.
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.
3.
Harris, M., Taylor. G. Medical Statistics Made Easy 2nd ed., 2008.
4.
Hulley, Stephen B. Cummings, Steven R. Browner, Warren S. Grady, Deborah Newman, Thomas B. Designing Clinical Research. Fourth edition. Philadelphia: LWW, 2013.