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Clinical Research
Study Course Description
Course Description Statuss:Approved
Course Description Version:2.00
Study Course Accepted:26.08.2019 16:10:13
| Study Course Information | |||||||||
| Course Code: | ZFTK_036 | LQF level: | Level 7 | ||||||
| Credit Points: | 2.00 | ECTS: | 3.00 | ||||||
| Branch of Science: | 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: | Rīga, Dzirciema iela 16, zftk rsu[pnkts]lv, zftkrsu[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) | 13 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 26 | ||||
| Total Contact Hours | 34 | ||||||||
| Study course description | |||||||||
| Preliminary Knowledge: | Informatics, mathematics. | ||||||||
| Objective: | 1. Introduce students to the main scientific, statistical and ethical principles of clinical research. 2. Learn how to critically appraise scientific publications. 3. Discuss practical aspects of planning and conducting a research. | ||||||||
| Topic Layout (Full-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Evidence-based healthcare, types of clinical study design, the levels of evidence. | Lectures | 1.00 | auditorium | |||||
| 2 | Research planning. Study outcomes. | Lectures | 1.00 | auditorium | |||||
| 3 | Ethics in research. Statistical calculation, interpretation of the study results. | Lectures | 1.00 | other | |||||
| 4 | Organisation and supervision of clinical trials. Clinical research organisations. | Lectures | 1.00 | auditorium | |||||
| 5 | Basic principles of electronic information search. Finding the evidence: searching principles and study analysis. | Classes | 1.00 | auditorium | |||||
| 6 | Introduction. Types of study in medical research – observational studies. Principles of evidence based health care. Levels of evidence. | Classes | 1.00 | auditorium | |||||
| 7 | Types of study in medical research – experimental studies. Principles of evidence based health care. Levels of evidence. | Classes | 1.00 | auditorium | |||||
| 8 | Planning research. Methods for randomization and blinding. | Classes | 1.00 | auditorium | |||||
| 9 | Phase I research studies. | Classes | 1.00 | auditorium | |||||
| 10 | Phase II and III research studies. Study designs. | Classes | 1.00 | auditorium | |||||
| 11 | Primary and secondary research endpoints. | Classes | 1.00 | auditorium | |||||
| 12 | Research ethics. | Classes | 1.00 | auditorium | |||||
| 13 | Basic principles of descriptive and inferential statistics. Interpretation of results. | Classes | 2.00 | auditorium | |||||
| 14 | Pragmatic trials. Monitoring of adverse events. | Classes | 1.00 | auditorium | |||||
| 15 | Non-inferiority studies. | Classes | 1.00 | auditorium | |||||
| 16 | Bioequivalence and equivalence studies. | Classes | 1.00 | auditorium | |||||
| Assessment | |||||||||
| Unaided Work: | Reading assignments, analysis of a movie, reading and analysis of research publications, writing a research protocol. | ||||||||
| Assessment Criteria: | The final grade consists of: 40% group work (tests, lecture attendance, team member assessment, presentations, randomized controlled trial analysis), 20% written experimental study protocol, and 40% end-of-course written test. | ||||||||
| Final Examination (Full-Time): | Test | ||||||||
| Final Examination (Part-Time): | |||||||||
| Learning Outcomes | |||||||||
| Knowledge: | Upon completion of this course, students: 1. will describe types of research studies; 2. will know advantages and applications of various research methods; 3. will know criteria for critical appraisal of publications; 4. will identify ethical principles of research. | ||||||||
| Skills: | Upon completion of this course, students: 1. Will differentiate various research designs. 2. Will be able to evaluate quality of research methods. 3. Will be able to develop a protocol for a simple research project. 4. Will be able to interpret statistical results. 5. Will be able to discuss ethical issues. | ||||||||
| Competencies: | Upon completion of this course, students: 1. will be able to find research studies and critically appraise them; 2. will be able to evaluate applicability of the study results to patient care; 3. will be able to make ethical decisions in research setting. | ||||||||
| Bibliography | |||||||||
| No. | Reference | ||||||||
| Required Reading | |||||||||
| 1 | Cochrane library | ||||||||
| 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 | ||||||||
| 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. | ||||||||
