Biomarkers in Drug Development: A Handbook of Practice, Application and Strategy

摘要

With the awareness that drug development has had diminishing success over the last 10 to 15 years, there has been an increasing consideration of ways to triage successful from nonsuccessful agents early in the drug development process. Biomarkers have come to forefront in this context both at the level of the FDA, in their articulation of the critical path, and many pharmaceutical companies that now require the codevelopment of a biomarker together with the new chemical entity. While many have looked to biomarkers as a panacea for the ills of drug development, many have realized that having a biomarker enhances the clarity of decisions in drug development but there remain many issues associated with their use. At times the hype about biomarkers has far outstripped their realistic contribution.