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Digital Study Design
Last Updated: 2026-02-05 16:37:06
Abstract
Digital health technology enables new study designs, including better evidence generation for value-based health care. This module focuses on the preparation of a study synopsis incorporating a digital technology and/or modern study concept. It tackles healthcare ecosystem complexity challenges and how modern trial designs and multistakeholder engagement can mitigate some of these challenges.
Objective
Participants will be able 1. to understand the added value of value-based health care 2. to apply the concepts of outcomes-based research and broad stakeholder value to increase the potential impact of the product studied in their clinical trial for the end user 3. to create their own negotiation framework to ensure they bring in all stakeholders' perspective along the value chain for their clinical trial: patient, provider, pharma/MedTech, payer, policy 4. to explain all components of a clinical trial using DHT 5. to apply the CAS knowledge to design their individual digital clinical study
Content
In this module, students will focus on different aspects of digital clinical trial design, e.g. on study designs for different research purposes, on gamification in healthcare, and on ethics of data. We are also addressing the challenges of ecosystem complexity, cost and product attrition onto the product lifecycle. We are discussing how modern clinical trial designs can mitigate some of these challenges by ensuring that sustainable value is created for all actors: not only the manufacturer and the patient, but also providers, regulators and payers. Students will learn about negotiation strategies and apply the principles of value-based health care. At the end of the module, students will discuss how DHT and/or modern study designs can be applied to their individual digital clinical trial idea.
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 | Digital Study Design |
|
15 h semesterly |