Clinical Research

Study Course Description

Course Description Statuss:Approved

Course Description Version:5.00

Study Course Accepted:19.08.2021 16:59:14

Study Course Information
Course Code:		ZFTK_048		LQF level:		Level 7
Credit Points:		3.00		ECTS:		4.50
Branch of Science:		Pharmacy; Social Pharmacy		Target Audience:		Pharmacy
Study Course Supervisor
Course Supervisor:		Elita Poplavska
Study Course Implementer
Structural Unit:		Department of Applied Pharmacy
The Head of Structural Unit:
Contacts:		Riga, 16 Dzirciema Street, zftkrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)		2	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		4
Classes (count)		4	Class Length (academic hours)		3	Total Contact Hours of Classes		12
Total Contact Hours								16
Full-Time - Semester No.2
Lectures (count)		3	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		6
Classes (count)		13	Class Length (academic hours)		2	Total Contact Hours of Classes		26
Total Contact Hours								32
Study course description
Preliminary Knowledge:
Informatics, mathematics
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.
Topic Layout (Full-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Introduction. Basic principles of evidence-based information search and citation formation principles.			Lectures		1.00	auditorium
2	Types of clinical study design, the levels of evidence.			Lectures		1.00	auditorium
3	Pharmaceutical information. Basic principles of electronic information search. Basic principles of citation formation.			Classes		1.00	auditorium
4	Basic principles of electronic information search. Finding the evidence: searching principles and study analysis. Evidence-based medical databases, their use.			Classes		1.00	auditorium
5	Types of study in medical research – observational studies. Principles of evidence based health care. Levels of evidence.			Classes		1.00	auditorium
6	Types of study in medical research – experimental studies. Principles of evidence based health care. Levels of evidence.			Classes		1.00	auditorium
7	Research planning. Study outcomes.			Lectures		1.00	auditorium
8	Ethics in research. Statistical calculation, interpretation of the study results.			Lectures		1.00	auditorium
9	Organisation and supervision of clinical trials. Clinical research organisations.			Lectures		1.00	auditorium
10	Planning research. Methods for randomization and blinding.			Classes		1.00	auditorium
11	Phase I research studies.			Classes		1.00	auditorium
12	Phase II and III research studies. Study designs.			Classes		1.00	auditorium
13	Primary and secondary research endpoints.			Classes		1.00	auditorium
14	Research ethics.			Classes		1.00	auditorium
15	Basic principles of descriptive and inferential statistics. Interpretation of results.			Classes		2.00	auditorium
16	Pragmatic trials. Monitoring of adverse events.			Classes		1.00	auditorium
17	Non-inferiority studies.			Classes		1.00	auditorium
18	Bioequivalence and equivalence studies.			Classes		1.00	auditorium
19	Systematic reviews and meta-analyses, their assessment.			Classes		3.00	auditorium
Topic Layout (Part-Time)
No.	Topic			Type of Implementation		Number	Venue
10	Planning research. Methods for randomization and blinding.			Lectures		1.00	auditorium
11	Phase I research studies.			Classes		1.00	auditorium
12	Phase II and III research studies. Study designs.			Lectures		1.00	auditorium
13	Primary and secondary research endpoints.			Classes		1.00	auditorium
15	Basic principles of descriptive and inferential statistics. Interpretation of results.			Lectures		1.00	auditorium
16	Pragmatic trials. Monitoring of adverse events.			Classes		1.00	auditorium
18	Bioequivalence and equivalence studies.			Lectures		1.00	auditorium
19	Systematic reviews and meta-analyses, their assessment.			Classes		1.00	auditorium
Assessment
Unaided Work:
Reading assignments, analysis of a movie, reading and analysis of research publications, writing a research protocol, creating presentations.
Assessment Criteria:
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.
Final Examination (Full-Time):		Exam (Written)
Final Examination (Part-Time):
Learning Outcomes
Knowledge:		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:		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.
Competencies:		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.
Bibliography
No.	Reference
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.