Preparation for multicenter clinical trial

Purpose and goal:

We conducted a pilot study with a urology clinic where prototype adaption based on feedback and requirements were carried out. Additionally, an international consortium including Karolinska Institutet, Region Kronoberg, Umeå University, CHROMagar (France), University of Oxford (UK), and University of Rennes (France) was formed to seek EU funding for the development of a multicenter clinical trial.

Finally, the consortium established a study protocol for comparative multicenter clinical studies to collect data for our CE IVDR application. Expected results and effects:

We have gained valuable experience in conducting a study in primary care/point-of-care settings and have assembled a robust consortium with an impressive range of competences. This accumulated experience and our consortium have empowered us to develop a strong study protocol and compose a compelling application for Eureka/Eurostars funding in early 2024.

Additionally, we have opted to incorporate an additional work package into our draft for the development and testing of added functionality of antibiotic susceptibility testing. Approach and implementation:

The iterative process of the pilot study where insights led to prototype adoptions and understanding our intended users requirements has positioned us well to deliver an effective and user-friendly solution. We are extremely pleased with the consortium we have assembled across Sweden, the UK, and France to seek EU funding, and to conduct multicenter clinical trials.

With this network of well-respected universities, we will be able to conduct high-quality, objective clinical trials and kickstart our marketing efforts in our primary target markets.