Research using Real World Data II – Advanced Trial Designs
Short Course

Overview

Degree
Kurs
Duration
2 days / 2 x 4 h in the afternoons
Fee
CHF 750
Language
Englisch

This advanced compact course explores innovative and complex clinical trial designs beyond traditional randomized controlled trials (RCTs). Tailored for PhD candidates, the course provides a deep dive into adaptive platform trials, basket and umbrella trials, Trials within Cohorts (TwiCs), modern approaches to cluster-randomized trials (including stepped-wedge), and pragmatic designs integrated in clinical practice. The focus is on the methodological concepts, regulatory considerations, and practical implementation.

Participants will learn how to critically assess and apply advanced trial designs to address challenges in modern clinical research. The course combines theoretical instruction with real-world examples and interactive group work to foster a strong understanding of design selection, operational feasibility, and statistical analysis.

Learning Objectives:

  • Understand the rationale and structure of advanced clinical trial designs
  • Examine master protocols: platform, basket, and umbrella trials
  • Gain insights into TwiCs, pragmatic and modern cluster trial designs and decision-making
  • Evaluate regulatory perspectives and ethical considerations
  • Apply design strategies to real-world clinical research scenarios

Further information:

Research using Real World Data II - Advanced Trial Designs
  • Afternoon sessions with expert-led lectures, interactive discussions, group exercises, and pre-readings
  • Case-based learning using examples from ongoing clinical research

15 hours of workload. This course can be combined with the course Research using Real-World Data I or module 4 (Randomized Controlled Trials) from the EHRM course to obtain 1 ECTS.

If all requirements have been met, you will receive a certificate for 15 hours of workload.

To add this course to your academic record, please create a Learning Contract on MOnA (choosing your supervisor as the assessor and pass/fail as assessment) before the start day of the course and follow the instructions of your respective faculty.

This course is open for everyone who is interested exploring innovative and complex trial designs beyond RCTs. The course is specifically tailored for PhD students of the PhD subject Clinical Research and related disciplines enrolled at the University of Basel, Faculty of Medicine.

Moreover, PhD students of the other PhD subjects of the Faculty of Medicine (Biomedical Engineering, Biomedical Ethics, Medicines Development, Nursing Science, Public Health/ Epidemiology or Sport Science) are eligible to register for the course.

Prerequisites:
Solid understanding of conventional clinical trial methodology and biostatistics. Solid understanding can be obtained e.g., in the course Real World Data I – Principles and Methodologies.

Minimum 8 and maximum 18 registered participants.

  • Dr. Andrea Kiemen

Mareike Gräter
Training and Education
Departement of Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel

mareike.graeter@usb.ch
Tel. +41 61 556 59 76
Weiterbildungen Departement Klinische Forschung

Available Mon-Thu 08.30h - 13.30h

Fee CHF 750 *)
The course fee includes course materials and provision during coffee/tea breaks.

*)The Department of Clinical Research (DKF) offers training grants for members of DKF research groups which result in a reduced fee of CHF 375. Please note, that training grants can only be offered to DKF clinical research group members, who are working at the group leaders’ local study center.

Medical Faculty of the University of Basel

Organiser
Department of Clinical Research, University of Basel, c/o University Hospital Basel

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