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Clinical Research and Analysis

Study Course Description

Course Description Statuss:Approved
Course Description Version:1.00
Study Course Accepted:20.03.2024 16:33:09
Study Course Information
Course Code:ZFTK_061LQF level:Level 7
Credit Points:2.67ECTS:4.00
Branch of Science:Basic Sciences of Medicine, including Pharmacy; Social PharmacyTarget 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, zftkatrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)4Lecture Length (academic hours)2Total Contact Hours of Lectures8
Classes (count)5Class Length (academic hours)3Total Contact Hours of Classes15
Total Contact Hours23
Full-Time - Semester No.2
Lectures (count)0Lecture Length (academic hours)0Total Contact Hours of Lectures0
Classes (count)8Class Length (academic hours)3Total Contact Hours of Classes24
Total Contact Hours24
Study course description
Preliminary Knowledge:
Informatics, mathematics
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.
Topic Layout (Full-Time)
No.TopicType of ImplementationNumberVenue
1Basic principles of evidence-based information search.Lectures1.00auditorium
2Types of clinical study design, the levels of evidence.Lectures1.00auditorium
3Design of experimental studies. Evaluating the efficacy and safety of medicines.Lectures1.00auditorium
4Basic statistical principles for clinical trialsLectures1.00auditorium
5Basic principles of evidence-based information search. PICO formulation.Classes1.00auditorium
6Observational and descriptive studies.Classes1.00auditorium
7How to read a scientific paper?Classes1.00auditorium
8Basic principles of experimental research studiesClasses2.00auditorium
9Efficacy and effectiveness of medicinesClasses1.00auditorium
10Primary and secondary endpoints.Classes1.00auditorium
11Ethics of clinical trialsClasses1.00auditorium
12Basic principles of descriptive and inferential statistics. Interpretation of results.Classes2.00auditorium
13Non-inferiority studies and bioequivalence studies.Classes1.00auditorium
14Systematic reviews and meta-analyses, their assessment.Classes2.00auditorium
Topic Layout (Part-Time)
No.TopicType of ImplementationNumberVenue
10Primary and secondary endpoints.Classes1.00auditorium
12Basic principles of descriptive and inferential statistics. Interpretation of results.Lectures1.00auditorium
14Systematic reviews and meta-analyses, their assessment.Classes1.00auditorium
Assessment
Unaided 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.
Assessment Criteria:
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.
Final Examination (Full-Time):Exam (Written)
Final Examination (Part-Time):
Learning Outcomes
Knowledge: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: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.
Competencies: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.
Bibliography
No.Reference
Required Reading
1Kokreina apvienības veidotie sistemātiskie pārskati
2Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials. Springer, 2015.
3Greenhalgh, T.How to read a paper. BMJ Books, 2014. p.238
4US National Library of Medicine National Institutes of Health datubāzes
5Ārvalstu studentiem/For international students
6Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials. Springer, 2015.
7Greenhalgh, T.How to read a paper. BMJ Books, 2014. p.238
Additional Reading
1Brody, T. Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Burlington: Academic Press, 2016.
2Hammond, Flora Malec, James F. Nick, Todd Buschbacher, Ralph M. Handbook for Clinical Research : Design, Statistics, and Implementation. New York, NY: Demos Medical, 2015.
3Harris, M., Taylor. G. Medical Statistics Made Easy. 2021
4Hulley, Stephen B. Cummings, Steven R. Browner, Warren S. Grady, Deborah Newman, Thomas B. Designing Clinical Research. Fourth edition. Philadelphia: LWW, 2013.
5Balakrishnan, N. Methods and Applications of Statistics in Clinical Trials Volume 1, Principles, Trials, and Designs Concepts, Principles, Trials, and Designs. Wiley. 2014.
6Machin, D., & Fayers, P. Randomized Clinical Trials : Design, Practice and Reporting. Chichester: John Wiley & Sons. 2010.
7Brody, Tom. Clinical Trials. San Diego: Elsevier Science & Technology. 2016.