You must believe that biomarkers are important because you are reading this newsletter, and, more to the point, you are reading this Editor's Corner. But to support what we believe, the importance of biomarkers is being validated by regulatory authorities and by guidelines.
Last week, the EMA issued a positive opinion on the use of an imaging-based biomarker to recruit patients into Alzheimer's disease clinical trials, the first time a biomarker of this type has been granted a positive opinion by a regulatory agency. This week, the National Institute on Aging and the Alzheimer's Association (NIA-AA) issued guidelines that include the use of biomarkers to support the postmortem diagnosis of Alzheimer's disease. Though diagnoses after death may seem of scant use to families, they are vital to support research, particularly of diagnostics.
Biomarkers have roles all the way through clinical development of therapeutics and diagnostics. They can be used to recruit patients into clinical trials, either by ensuring that the diagnosis is correct, as in the biomarker approved by the EMA above, or by selecting the appropriate subgroup that might respond to the drug. They can also help to monitor the progress of disease and the success (or failure) of the drug, and be used as a surrogate endpoint, substituting for a clinical endpoint to make a trial shorter, or the results clearer and more practically applicable. Of course, biomarkers are also important for physicians and patients by providing a route to personalized medicine.
So... that's the importance of biomarkers in a nutshell. As we look out over 2012 (or the rest of 2012--it is February already!) we look to another year of new breakthroughs in biomarkers, and their inclusion in more guidelines and recommendations. It should be an exciting year. — Suzanne Elvidge (email)