A roadmap for biomarker implementation

A recent paper published in the European Journal of Clinical Investigation has proposed a roadmap for taking newly discovered and verified proteomic biomarkers into into clinical practice. Drawn up by an expert panel of 37 scientists from 36 organisations around the world, they dismiss the popular belief that the major effort is involved in the initial identification and verification and that a relatively minor amount of work is required thereafter for implementation. Implementation takes much longer than anticipated, and is full of risks and additional obstacles.

"The implementation effort needs to involve a wide variety of stakeholders, including clinicians, statisticians, health economists, and representatives of patient groups, health insurance, pharmaceutical companies, biobanks, and regulatory agencies," they say. The steps include access to a suitable multidisciplinary panel which will evaluate evidence and provide guidance for further study design.