Identifying the right patients for the right drug at the right time is a major goal for improving patient care. Using biomarkers to help us personalise medicine is one strategy. The discovery of new biomarkers and the development of new biomarker-directed therapies raise high hopes for personalised medicine. Despite their promise, claims of clinical benefit of biomarker use still requires careful evaluation. This unit will teach candidates how to embed biomarker studies and translational research into clinical trial designs. The special skills and techniques of translational research will be highlighted in this unit. Candidates will understand the potential uses for biomarkers in clinical practice; how to use study designs relevant for biomarker evaluation and how to incorporate biomarker studies and biospecimen (tissue and blood) collection into clinical research projects. Candidates will learn the difference between prognostic, predictive and surrogate biomarkers and biostatistical considerations in their analysis. The complexities of international regulations regarding patient consent, biospecimen collection and shipment will be highlighted.
discussion groups and problem based learning
2x short-answer quizzes (2x10%), 2x short-answer assignments (2x40%)
Recommended reading: Altman DG, McShane LM, Sauerbrei W, Taube SE (2012)Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration.PLoS Med (5): e1001216. doi:10.1371/journal.pmed.1001216