Definition of biomarkers and efficacy end-points

3. Challenges for Biomarkers in Medicines Development

3.3. Ethical Challenges

Many ethical issues are seen in biomarker research. These issues often have to do with the storage and use of tissue samples, and how associated personal medical data are handled.

In addition, wider concerns have been raised about the impact of targeted medicine which is largely based on biomarker research. One concern is that targeted treatments only benefit the sub-population of patients that respond to them. Who will then make sure that medicines are developed for those who fall outside of this sub-population?