| Dozent/in |
Prof. Dr. med. François Curtin |
| Veranstaltungsart |
Workshop |
| Code |
FS251601 |
| Semester |
Frühjahrssemester 2025 |
| Durchführender Fachbereich |
Medizin |
| Termin/e |
Mi, 05.02.2025, 17:00 - 19:00 Uhr
Mi, 19.02.2025, 17:00 - 19:00 Uhr
Mi, 19.03.2025, 17:00 - 19:00 Uhr
Mi, 16.04.2025, 17:00 - 19:00 Uhr
Mi, 21.05.2025, 17:00 - 19:00 Uhr |
| Turnus |
Once per year |
| Inhalt |
The course in the spring semester also contains 5 2-hour sessions: 1) Common designs of studies: Parallel group trials, cross-over trials, advantages, disadvantages and biases associated with the designs; how to make the choice. 2) Regulatory and ethical aspects: Introduction to some essential laws and guidelines such as the Swiss Human research act and related ordinances; ICH E6 R2 – Good Clinical Practice; submission to ethics commissions and to Swissmedic. 3) Advanced concepts for clinical studies I: Interim analyses; group sequential trials; adaptive clinical trials; interests and limitations of these designs. 4) Advanced concepts for clinical studies II: Trials for precision medicine (umbrella and basket trials); digital and virtual clinical trials which can shape a new era in clinical research. 5) Project presentation / Journal Club: - research projects of participants can be presented; relevant publications will be presented by participants and discussed. |
| Lernziele |
This is a training for clinical researchers at LUKS and PhD/Master students at Uni Luzern which will support them to understand the fundamental principles of clinical research in order to plan, organize and perform clinical research.
The course introduces the scientific and regulatory concepts of clinical studies and trials which make them the gold standard for evidence based medicine.
The course mixes some essential theoretical concepts of clinical and health research with their application, discussed during workshops and practical exercises.
After following the module with both courses, the students should be able to design a study or trial according to rigorous scientific and ethics standards and be accepted by funding institutions.
The module with both courses will also allow the students to read critically the scientific literature and appreciate the quality and limitations of clinical research. |
| Voraussetzungen |
Knowledge of health science or medicine acquired with a Bachelor degree; interest for research.
Attendance to the lectures and active participation in workshops and exercises. |
| Sprache |
Englisch |
| Anmeldung |
https://forms.office.com/e/sdnngin8np
https://elearning.hsm-unilu.ch/course/view.php?id=865
|
| Prüfung |
Attendance and active participation in workshop or exercise part. |
| Abschlussform / Credits |
Bestätigte Teilnahme / 1 Credits
|
| Hinweise |
Registration is binding in order to receive credits.
Teaching method(s)
Lectures, workshops, practicals. For each session, the theory is introduced during the first hour with a lecture; the second hour is dedicated to workshops or exercises where the theoretical concepts are discussed or exercised with practical examples, notably from the clinical research literature.
The course takes place at the Lucerne Cantonal Hospital in House 10 (Room Pilatus 4.08) |
| Hörer-/innen |
Nein |
| Kontakt |
francois.curtin@luks.ch |
| Material |
Slides for the theoretical part, scientific articles for the workshops – all available electronically. |
| Literatur |
Literature/Readings: Slides of the lectures.
Scientific papers as examples of the theory discussed in the course.
Some national or international guidelines related to clinical research will be provided as references.
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