I am excited to be joined by one of the keynote speakers from HIMSS13 conference Dr Eric Topol – Author of
The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care and has been named in the list of the Top 100 Most Influential Physician Executive in Healthcare, 2012 by Modern Healthcare
We will be discussing amongst other things the challenge of clinical research as the speed of innovation in medicine accelerates. There is a better way as Dr Topol describes here: Get Rid of the Randomized Trial; Here’s a Better Way
Historically we ran large scale trials that were blinded – in other words patients would either receive treatment or a placebo – neither they nor their treating clinicians would know which protocol they were on. At the end of the results the data would be analyzed and demonstrate either the positive benefit fo the treatment or not.
But what if giving the patient results in the death of patients – is it ethical to give a placebo when this results in the death of patents that could have benefitted from the treatment.
In the new style of trial we use surrogate markers for disease in a specific genetically similar group:
Researchers will be testing a drug that binds amyloid, a monoclonal antibody, in just  family members. They’re not following these patients out to the point of where they get dementia. Instead, they are using surrogate markers to see whether or not the process of developing Alzheimer’s can be blocked using this drug. This is an exciting way in which we can study treatments that can potentially prevent Alzheimer’s in a very well-demarcated, very restricted population with a genetic defect, and then branch out to a much broader population of people who are at risk for Alzheimer’s. These are the types of trials of the future and, in fact, it would be great if we could get rid of the randomization and the placebo-controlled era going forward.
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