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Fundamental concepts for clinical research – an introduction, part I


Dozent/in Prof. Dr. med. François Curtin
Veranstaltungsart Workshop
Code HS251682
Semester Herbstsemester 2025
Durchführender Fachbereich Medizin
Termin/e Mi, 01.10.2025, 17:00 - 19:00 Uhr
Mi, 22.10.2025, 17:00 - 19:00 Uhr
Mi, 05.11.2025, 17:00 - 19:00 Uhr
Mi, 26.11.2025, 17:00 - 19:00 Uhr
Mi, 10.12.2025, 17:00 - 19:00 Uhr
Weitere Daten The course takes place at the Lucerne Cantonal Hospital in House 10. Exact Room number can be found on moodle.
Inhalt The course in the autumn semester contains 5 2-hour sessions:

1) Methodology for clinical research: How to formulate the right research questions; study goals and corresponding endpoints; some statistical distributions of endpoints.
2) Basic statistical thinking: Hypothesis testing and type I/II errors; power calculation; biostatistical analysis toolkit with examples of important statistical tests.
3) Epidemiological studies: Different types of studies (cohort and case control studies, survey); analysis of epidemiological studies; differences between epidemiological studies compared to clinical studies.
4) Clinical studies: - Basic methodological concepts (randomization; choice of controls; placebo; blinding) supporting the optimal conditions for the inference; practical aspects of a study.
5) Project presentation / Journal Club: - research projects of participants can be presented; relevant publications will be presented by participants and discussed.

The course in the spring semester also contains 5 2-hour sessions:

6) Common designs of studies: Parallel group trials, cross-over trials, advantages, disadvantages and biases associated with the designs; how to make the choice.
7) Studies for public health interventions: cluster clinical trials; sequential trials and interim analyses.
8) Advanced concepts for clinical studies I: Interim analyses; adaptive clinical trials; interests and limitations of these designs.
9) 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.
10) 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 and discussion of articles.

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 and understand the need to develop protocols according to good clinical practice and international directives for clinical research.

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://elearning.hsm-unilu.ch/course/view.php?id=952
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.

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.

Important Information for students from other universities: If you would like to have this course recognized at another university, you must register as an individual course participant via the website within the registration window: https://www.unilu.ch/studium/anmeldung-und-zulassung/anmeldung-einzelkursbesucher-und-einzelkursbesucherinnen/ . Confirmation is not possible without registration.
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