Tagged: trials

Tips for Success in Large Subject-Based IVD Studies

In development of IVDs, the transition to large subject-based studies is a major milestone in progress toward marketing approval. The test product has proven itself in reproducibility and validation studies, often involving banked samples. The developer can see years of effort at last culminating in revenue generation.  Only one step remains – a large subject-based… Read more »

DSMBs and Business Decisions in Clinical Research

Interim reviews in clinical trials have always been controversial in some circles because they require somebody to look at otherwise confidential data while a trial is in progress, raising the possibility of introducing bias. On the other hand, not letting anybody see interim data is a great way to have a trial with serious issues… Read more »