Ongoing Projects Research on Research
The Investigational Medicinal Product – Practical Academic Clinical Trial Toolbox for Decentralised Trials - IMP-PACT DCT
Project ID: RoR2026_022
Lead: Zoé Peña Aguirre, DCR Bern
Contacts: zoe.pena@unibe.ch
Contributors: tbd
Description:
IMP-PACT DCT develops a practical, Swiss-adapted operational toolbox for Direct-to-Patient (DtP) delivery of investigational medicinal products in decentralised and hybrid clinical trials. While DtP approaches can broaden access, improve recruitment and adherence, and enhance efficiency, they also introduce regulatory and operational complexities. The project consolidates current evidence, guidance, and legislation, translating fragmented recommendations into clear workflows, checklists, and decision tools aligned with Swiss regulations. Piloted across the SCTO Network, the toolbox is validated in real-world settings to establish practical, compliant standards for safe and efficient DCT implementation in Switzerland.
Key Objectives:
- Identify and extract operational data from DCTs with IMP delivery.
- Capture real-world workflows and current practices.
- Map Swiss regulatory requirements and compare with international frameworks.
- Develop practical workflows, checklists, and decision trees for Swiss IITs.
- Test usability and consistency of workflows across CTUs in a controlled setting.
- Disseminate results and make the toolbox widely accessible.
Methods:
- Targeted evidence review of DCT-related trials (in alignment with DCT Working Group)
- Stakeholder Interviews (CRCs, vendors, teams experienced in DtP delivery)
- Regulatory analysis
- Toolbox development
- Sandbox simulation to validate materials
- Iterative refinement of toolbox components and dissemination