Ongoing Projects Research on Research
Developing a National Risk‑Assessment Framework for Decentralised Clinical Trials: The Swiss-DCT-Risk Tool
Project ID: RoR2026_020
Lead: Anastasios Stathis (CTU-EOC/USI) & Paola Messina (CTU-EOC)
Contacts: anastasios.stathis@eoc.ch, paola.messina@eoc.ch
Contributors: tbd
Description:
This project aims at developing a structured national risk assessment tool (i.e., the Swiss-DCT-Risk tool) to support sponsors and Sponsor-Investigators in systematically evaluating the appropriateness and risk profile of elements to be possibly decentralised (e.g., remote consent, home nursing, telemedicine, product delivery, digital data capture) in clinical trials conducted in or from Switzerland. The tool provides a structured framework to ensure safe, high quality implementation of DCT components across Switzerland.
Key Objectives:
- To map the existing landscape of DTCs in Switzerland, including existing regulatory, ethical, and operational frameworks;
- To develop a structured, multi-domain risk assessment tool for elements to be possibly decentralised
- To gain a consensus from all Swiss CRCs about the tool and to have it tested
- To disseminate the risk-assessment tool and publish the overall results of the project
Methods:
- Mixed-methods approach (focus groups, surveys, probability/Impact matrix method, modified Delphi method)