| Dozent/in |
Dr. rer. pol. Dirk Lehnick |
| Veranstaltungsart |
Masterseminar |
| Code |
HS241312 |
| Semester |
Herbstsemester 2024 |
| Durchführender Fachbereich |
Gesundheitswissenschaften |
| Studienstufe |
Master |
| Termin/e |
Do, 26.09.2024, 16:15 - 18:00 Uhr, E.509
Do, 03.10.2024, 16:15 - 18:00 Uhr, E.509
Do, 10.10.2024, 16:15 - 18:00 Uhr, E.509
Do, 17.10.2024, 16:15 - 18:00 Uhr, E.509
Do, 24.10.2024, 16:15 - 18:00 Uhr, E.509
Do, 31.10.2024, 16:15 - 18:00 Uhr, E.509
Do, 07.11.2024, 16:15 - 18:00 Uhr, E.509
Do, 14.11.2024, 16:15 - 18:00 Uhr, E.509
Do, 21.11.2024, 16:15 - 18:00 Uhr, E.509
Do, 28.11.2024, 16:15 - 18:00 Uhr, E.509
Do, 05.12.2024, 16:15 - 18:00 Uhr, E.509
Do, 12.12.2024, 16:15 - 18:00 Uhr, E.509
Do, 19.12.2024, 16:15 - 18:00 Uhr, E.509
Fr, 17.01.2025, 12:15 - 13:45 Uhr, HS 9 (Prüfung)
Do, 05.06.2025, 08:15 - 09:45 Uhr, HS 4 (Wiederholungsprüfung) |
| Weitere Daten |
Major Course for MSc Health Sciences students (can be credited as a core course in the majors Health Services Research and Health Data Science; also open to students from other majors or study programs). |
| Umfang |
2 Semesterwochenstunden |
| Inhalt |
The course will focus in particular on drug trials, which for various reasons set the gold standard in evidence-based medicine and the ethical and regulatory requirements for clinical trials.The lecturer has also worked in commercial drug development for many years. Many real examples and case studies will therefore be used to learn the basics of such studies and to discuss ethical issues. Studies from very different indications will be covered and topics such as diversity (ethnic, sex/gender, age groups), vaccination studies, gene therapy/genome editing, role of AI will also be discussed. We will recognize how a regulatory framework helps to ensure the well-being of the study participants and furthermore the integrity and quality of the trials, their data and the resulting scientific findings and conclusions. Clinical Trials:
• Interventional vs. non-interventional studies
• Trials involving medicinal products / Phases of drug development
• Study objectives
• Typical study designs
• Randomization, blinding, study documentation, sample size determinationGood Clinical Practice (GCP) and Research Ethics:
• Ethical principles for research
• History of clinical research ethics (incl. case studies)
• Good Clinical Practice guidelines / legal framework
• Roles, tasks and responsibilities in clinical studies as defined by ICH-GCP
• Patient information and consent
• Clinical trial application / Ethics committees / Competent authorities
• Scientific requirements and practical implementation issues
• Quality management in clinical trials
• Patient information and consent
• Data collection and handling / Statistical planning and analysis
• Adverse events and safety reporting |
| Schlagworte |
Gender/Diversity |
| Lernziele |
• Gain basic knowledge of principles of clinical trials
• Understand the historical context and main concepts of research ethics and Good Clinical Practice (GCP) guidelines
• Know roles, tasks and responsibilities in clinical studies as defined by ICH-GCP |
| Voraussetzungen |
Diligence and eagerness to learn. |
| Sprache |
Englisch |
| Begrenzung |
priority Master Health Sciences students |
| Anmeldung |
https://elearning.hsm-unilu.ch/course/view.php?id=773
|
| Prüfung |
The course credits will be earned by passing a written exam in at the end of the semester or, in case of failure of the written test, the passing of a compensation test during the subsequent semester. |
| Abschlussform / Credits |
written exam / 3 Credits
|
| Hinweise |
Teaching method(s):
The module mainly consists of in-class teaching complemented by practical learning sessions and problem discussions. Slides and materials of in-class teaching sessions will be electronically available for recapitulation. Parts of the course will require self-study conducted between in-class lectures based upon case studies and documents which will be electronically available or will be handed out during the sessions. |
| Hörer-/innen |
Nein |
| Kontakt |
dirk.lehnick@unilu.ch |
| Material |
All teaching material incl. case studies will be provided via the learning management system or as handout. |
| Literatur |
Swiss Academy of Medical Sciences (SAMS) handbook “Research with human subjects” (2nd edition, 2015)Emanuel et al. (2000) What makes clinical research ethical; JAMA 283(20):2701-2711ICH GCP Guideline with Integrated Addendum E6(R2), Step 4 (Nov 2016) |