.
Basic Principles of Clinical Trials and Drug Registration
Study Course Description
Course Description Statuss:Approved
Course Description Version:6.00
Study Course Accepted:28.08.2023 11:37:47
| Study Course Information | |||||||||
| Course Code: | FLK_047 | LQF level: | Level 7 | ||||||
| Credit Points: | 2.00 | ECTS: | 3.00 | ||||||
| Branch of Science: | Clinical Medicine | Target Audience: | Medicine | ||||||
| Study Course Supervisor | |||||||||
| Course Supervisor: | Irēna Teterina | ||||||||
| Study Course Implementer | |||||||||
| Structural Unit: | Department of Pharmacology | ||||||||
| The Head of Structural Unit: | |||||||||
| Contacts: | Riga, Konsula street 21, 1st floor; Irena[pnkts]Teterina rsu[pnkts]lv; Indra[pnkts]Dumbergarsu[pnkts]lv; +371 67613517 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| 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 | ||||||||
| 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: | General pharmacology, search and analysis skills of research materials. | ||||||||
| Objective: | Introduce students to the most important aspects of planning, organising and managing clinical trials and publishing their results. Develop skills in interpretation and analysis of the clinical research results. Provide an insight into the documentation required and legal basis for the registration of medicinal products. | ||||||||
| Topic Layout (Full-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | The journey of a medicine from lab to shelf. Trials of new and modern drugs and appliances. Procedures for conducting clinical trials on medicinal products and medical devices (clinical trials). The process of registration of drugs. Inclusion of medicinal products in the EU Community Register of Medicinal Products. Procedure for advertising drugs. | Classes | 1.00 | auditorium | |||||
| 2 | Clinical Trial Regulation and controls. The rules to be followed during the research as well as the necessary documentation in these processes. Qualification requirements for researchers and the scope of specific knowledge. Guidelines for good clinical practice. | Classes | 1.00 | auditorium | |||||
| 3 | Four phases of drug clinical trials: Phases I to IV. Types of clinical trial design. | Classes | 1.00 | auditorium | |||||
| 4 | Research protocol, stakeholders, responsibility, selection of research design. | Classes | 1.00 | auditorium | |||||
| 5 | The European Union Clinical Trials Register – information on clinical trials of medicinal products in the countries of the European Economic Area, including Latvia, and the possibility to participate in them. | Classes | 1.00 | auditorium | |||||
| 6 | Monitoring and control of research progress. | Classes | 1.00 | auditorium | |||||
| 7 | Informed consent of the patient for participation in a clinical trial. Its content and consent process. | Classes | 1.00 | auditorium | |||||
| 8 | The activities and competence of ethics commissions. Ethical issues of research. | Classes | 1.00 | auditorium | |||||
| 9 | Research results, interpretation, and publishing. Legal and ethical considerations. | Classes | 1.00 | auditorium | |||||
| 10 | Studies in patients with curable diseases. Psychological, ethical and legal considerations. Survival studies: oncology. Psychological, ethical and legal considerations. | Classes | 1.00 | auditorium | |||||
| Assessment | |||||||||
| Unaided Work: | Presentations, literature review. 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: | The study program is developed in the form of seminars and lectures. A summary of individual reflections and, most importantly, from each student, mutual exchange of ideas and discussion. Examination. | ||||||||
| Final Examination (Full-Time): | Exam (Written) | ||||||||
| Final Examination (Part-Time): | |||||||||
| Learning Outcomes | |||||||||
| Knowledge: | Upon successful completion of the course, the student will have acquired knowledge that will allow: 1. Understand why and how clinical trials are conducted and who assumes responsibility for conducting and/or financing a clinical trial; 2. Provide information on the discovery of new medicines, the registration process and the launch of medicinal products into the market; 3. Differentiate between bioequivalence and therapeutic equivalence, generic and original drugs, megabrands; 4. Explain the nature of cost-efficiency in pharmacology; 5. Be competent in the principles of communication and ethics of the doctor and the pharmaceutical industry. | ||||||||
| Skills: | Students will be able to evaluate clinical trial documentation, monitoring of clinical trials, and assess the relevance of clinical research to the principles of good clinical practice; will have a good knowledge of the European Union (EU) Clinical Trials Register in EU Member States and Iceland, Liechtenstein and Norway; will be able to find information on ongoing phase II-IV studies in adults and all paediatric clinical trials. | ||||||||
| Competencies: | On completion of the course, students will be able to apply their theoretical knowledge of the clinical trial process, the procedures required to conduct the study, permits, certificates of good clinical practice and good manufacturing practice. Will be able to independently obtain, select, and analyze research information by the following search parameters: country, age, gender, and study phase, study status, diagnosis, etc., as well as the possibility to contact the sponsor of the particular study, if necessary. Will demonstrate a scientific approach to solving topical issues, as well as to specific literature. | ||||||||
| Bibliography | |||||||||
| No. | Reference | ||||||||
| Required Reading | |||||||||
| 1 | https://www.clinicaltrialsregister.eu/ | ||||||||
| 2 | Brody, Tom. Clinical Trials. 2nd Edition, 2016 | ||||||||
| 3 | Trends in Pharmacological Sciences. Artificial Intelligence for Clinical Trial Design. 2019 | ||||||||
| Additional Reading | |||||||||
| 1 | https://www.zva.gov.lv | ||||||||
| 2 | Pragmatic Clinical Trials | ||||||||
