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From Clinical Problem to Research Question
Last Updated: 2026-02-05 16:14:38
Abstract
The course will discuss how to design a clinical study and addresses topics such as the quantification of medical need, the reduction of unnecessary complexity, and the identification of clinical outcome measures.
Objective
After taking this course, participants will be able - to read a clinical study publication in a structured way; - to apply analytical schemes and frameworks to appraise a clinical study; - to understand structure and content of a study synopsis - to understand the concept of object design and to apply this concept in the planning of a study; - to explain why the participants of a study are randomized, and to understand the consequences of randomization for the conduct of the study; - to understand how to deal with AE / SAE and how to report them; - to describe and explain clinical outcomes, to differentiate between different clinical outcome assessments, to explain important aspects of cross-cultural use of patient-reported outcomes and basic psychometric properties; - to explain main outcome categories relevant for the healthcare system
Content
The topics are: 1. Critical appraisal of clinical research literature, application of evidence levels, and utilization of checklists 2. Designing clinical studies with a focus on object design, diagnostic and prognostic studies, and consideration of confounding factors. 3. Planning and conducting clinical studies in an ethical way 4. Outcomes in clinical studies, definition, hierarchies, Clinical Outcome Assessments (COA), psychometric methods for validating Patient-Reported Outcomes (PROs), and cross-cultural adaptations. 5. Feasibility of clinical studies 6. Healthcare system relevant outcomes and basic aspects of Health-Technology Assessment This first module of the CAS ETH in Modern Concepts in Clinical Research (CAS ETH MCCR) provides an overview of the fundamentals of clinical studies, which will be applied in a study synopsis on a self-selected or assigned topic during the CAS ETH MCCR programme. Thus, it serves as a starting point for the subsequent modules, where the knowledge will be deepened, and new methods (e.g., decentralized trials) and the application of digital technologies (e.g., digital measures and remote monitoring) will be introduced. The course includes input sessions and workshops, remote preparation, and blended learning. Complimentary learning material is provided online.
General Information
- Language
- English
- Levels
- NDS , WBZ
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise | From Clinical Problem to Research Question | No time listed | 24 h semesterly |