http://www.pastelbioscience.co.uk/resources/blog.html Stephen Osborne 2013-11-23T23:00:00Z http://www.pastelbioscience.co.uk/resources/blog.html Stephen Osborne 2013-11-23T23:00:00Z

While the basic rules for assessing good biomarkers have been known for many years (1, 2) more recently there has been a plethora of publications in both scientific journals (see as examples 3, 4, 5) and web-based articles (6, 7, 8) covering the thorny issue of how biomarkers found in discovery programmes have then not progressed to fulfil their promise when in validation studies and as a consequence the dearth of new biomarkers reaching the clinic. Even the FDA has issued a Guidance document (9) setting out the process for "Qualifying" biomarkers (drug development tools, DDTs) to be used in the drug development process in the hope that more biomarkers may be employed.