.
Clinical Research and Analysis
Study Course Description
Course Description Statuss:Approved
Course Description Version:7.00
Study Course Accepted:20.03.2024 15:46:43
| Study Course Information | |||||||||
| Course Code: | ZFTK_054 | LQF level: | Level 7 | ||||||
| Credit Points: | 3.00 | ECTS: | 4.50 | ||||||
| Branch of Science: | Basic Sciences of Medicine, including 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, zftk rsu[pnkts]lv, +371 67061547 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| Lectures (count) | 4 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 8 | ||||
| Classes (count) | 8 | Class Length (academic hours) | 3 | Total Contact Hours of Classes | 24 | ||||
| Total Contact Hours | 32 | ||||||||
| Full-Time - Semester No.2 | |||||||||
| Lectures (count) | 0 | Lecture Length (academic hours) | 0 | Total Contact Hours of Lectures | 0 | ||||
| Classes (count) | 5 | Class Length (academic hours) | 3 | Total Contact Hours of Classes | 15 | ||||
| Total Contact Hours | 15 | ||||||||
| 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. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Basic principles of evidence-based information search. | Lectures | 1.00 | auditorium | |||||
| 2 | Types of clinical study design, the levels of evidence. | Lectures | 1.00 | auditorium | |||||
| 3 | Design of experimental studies. Evaluating the efficacy and safety of medicines. | Lectures | 1.00 | auditorium | |||||
| 4 | Basic statistical principles for clinical trials | Lectures | 1.00 | auditorium | |||||
| 5 | Basic principles of evidence-based information search. PICO formulation. | Classes | 1.00 | auditorium | |||||
| 6 | Observational and descriptive studies. | Classes | 1.00 | auditorium | |||||
| 7 | How to read a scientific paper? | Classes | 1.00 | auditorium | |||||
| 8 | Basic principles of experimental research studies | Classes | 1.00 | auditorium | |||||
| 9 | Efficacy and effectiveness of medicines | Classes | 2.00 | auditorium | |||||
| 10 | Primary and secondary endpoints. | Classes | 1.00 | auditorium | |||||
| 11 | Ethics of clinical trials | Classes | 1.00 | auditorium | |||||
| 12 | Basic principles of descriptive and inferential statistics. Interpretation of results. | Classes | 2.00 | auditorium | |||||
| 13 | Non-inferiority studies and bioequivalence studies. | Classes | 1.00 | auditorium | |||||
| 14 | Systematic reviews and meta-analyses, their assessment. | Classes | 2.00 | auditorium | |||||
| Topic Layout (Part-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 9 | Efficacy and effectiveness of medicines | Lectures | 1.00 | auditorium | |||||
| 10 | Primary and secondary endpoints. | Classes | 1.00 | auditorium | |||||
| 12 | Basic principles of descriptive and inferential statistics. Interpretation of results. | Lectures | 1.00 | auditorium | |||||
| 14 | 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, 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 | |||||||||
| 1 | Kokreina apvienības veidotie sistemātiskie pārskati | ||||||||
| 2 | Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials. Springer, 2015. | ||||||||
| 3 | Greenhalgh, T.How to read a paper. BMJ Books, 2014. p.238 | ||||||||
| 4 | US National Library of Medicine National Institutes of Health datubāzes | ||||||||
| 5 | Ārvalstu studentiem/For international students | ||||||||
| 6 | Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials. Springer, 2015. | ||||||||
| 7 | Greenhalgh, T.How to read a paper. BMJ Books, 2014. p.238 | ||||||||
| Additional Reading | |||||||||
| 1 | Brody, T. Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Burlington: Academic Press, 2016. | ||||||||
| 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. 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. | ||||||||
| 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. | ||||||||
