Regulatory review of groundbreaking medical research in Sweden—benchmarking and proposals for improvement
| Reference number | |
| Coordinator | Karolinska Institutet - Karolinska Institutet Inst f klinisk neurovetenskap |
| Funding from Vinnova | SEK 994 152 |
| Project duration | April 2025 - April 2026 |
| Status | Ongoing |
| Venture | Regulation and cutting-edge technology |
| Call | Rules and instruments for cutting-edge technology |
Purpose and goal
We aim to streamline regulatory review of groundbreaking medical research in Sweden by building an open database and proposing improvements.
Expected effects and result
The project will result in a comprehensive open data resource and yearly reports offering benchmarking and recommendations for process improvements, to shorten the time from bench to clinic for groundbreaking Swedish medical research and innovation.
Planned approach and implementation
We will create an open database of records requested from the Swedish Ethics Review Authority and the Regional Animal Ethics Review Boards, which will contain information about applications such as project titles, approval numbers, sponsors, dates of application and decision. We will analyse numbers of applications and their characteristics, as well as partial lead times. We will estimate costs of the regulatory review system in time and money and propose improvements.