De-centralized clinical trials - Patient centric, carried out on remote and supported by virtual elements
| Reference number | |
| Coordinator | Läkemedelsverket |
| Funding from Vinnova | SEK 973 700 |
| Project duration | December 2020 - December 2021 |
| Status | Completed |
| Venture | 2017-01599-en |
Important results from the project
The project has in a concrete way, with focus on increased number of clinical trials in Sweden, contributed to the realization of the national life sciences strategy. Prerequisites for conducting clinical trials with decentralized elements in Sweden have been established during the project. The transparency of the conditions has increased, the regulatory risk for sponsors has decreased, and the possibility for patients to participate in clinical trials regardless of where they live has improved.
Expected long term effects
The fact that the pilot trials represent both academic and commercial sponsors and all phases of clinical trials shows that decentralised elements can be relevant for different types of trials.
Approach and implementation
Five pilot trials with different decentralised elements have been followed. These cases have been published on the Swedish Medical Products Agency´s website. Questions & answers about what is important to think about have been published. Advice meetings have taken place between the Swedish Medical Products Agency and individual sponsors. To further improve the conditions for decentralised clinical trials in Sweden, the continuing challenges has been discussed with key national actors.