Reducing the validation costs for infection-resistant biomaterials in clinical trials is a major challenge for society, and something the BDC aims to resolve.
In general, there are two ways to overcome this hurdle:
- Involve the UMCG. As basic scientific departments are embedded in the UMCG hospital environment, it is ideally equipped to formulate comprehensive protocols for the clinical evaluation of new anti-infection strategies. In cases where the number of patients required for clinical evaluation exceeds the number of patients available within the UMCG, or its affiliated hospitals, the UMCG has extensive collaborations ongoing with major hospitals in China, often exceeding the size of western hospitals by a factor of 5 to 10. The exchange and continuous management of UMCG developed protocols with Chinese hospitals, presents an added feature through which the BDC can execute large scale clinical validation studies.
- Smart selection of clinical end- points in a trial. By a better infection diagnosis during or directly after surgery, the BDC may be able to diagnose infection within the first weeks after surgery as a clinical endpoint instead of the time between surgery and visual signs of infection, often weeks or months after surgery.