Learning and confirming

The case studies we use here are meant to help you practice using the QOC to find the critical development path and translate questions to development outlines. We focus on the learning phase of the clinical development. As mentioned in Adam Cohen's Futurlab talk earlier in this module, the translation of the critical path to development outline and actual clinical studies is highly dependent on the availability and quality of methods to address the questions. Biomarkers are widely used in clinical development but vary enormously in quality and relevance to clinical endpoints.