Virtual Clinical Trials
| Reference number | |
| Coordinator | Läkemedelsverket |
| Funding from Vinnova | SEK 1 702 127 |
| Project duration | November 2019 - December 2020 |
| Status | Completed |
| Venture | 2017-01599-en |
Important results from the project
The maingoal - using the project in order to establish processes to catalyse and start real trials where datacollection and documentation is carried out fully or partially decentralized and/or virtually, is fulfilled with the pilot trials initiated by the project. The results from the project also contribute to a better understanding of what is actually required, both regulatory and practical, and to achieve compliance with current regulations.
Expected long term effects
The project has generated and resulted in both expectant and unexpected effects. The interest among the actors involved and the willingness to cooperate in order to thereby contribute, has consistently been very large. The project has also conveyed an important signal value in a global context - that Sweden is at the forefront and has a will and ambition that this type of testing can be carried out in Sweden in a predictable way. International pharmaceutical and CRO companies but also authorities and organizations have actively followed the project during its implementation.
Approach and implementation
The project has been carried out in an interaction between theory, analysis and practice. The MPA´s internal expertise and competence has been important in the interpretation of regulations. In parallel, the actors concerned have listed areas and issues where regulations and guidelines are perceived as unclear, which the project, with the support of internal expertise, worked to clarify. Thanks to the project´s five pilots, the authority and the project have also received concrete issues to evaluate and analyze and which are in the right context to make a risk-based assessment.