For years, there’s been talk about making the clinical trial process more standardized, and cheaper, so that the same rules would apply each time a study needed to be run. There’s even been discussion that what are known as pragmatic trials — large, simple, randomized studies in which less data are collected — might be conducted using electronic health records. But that hasn’t happened at the pace it should.
The reason involves another part of the problem. Clinical trials are principally run by drug and medical device companies in order to obtain regulatory approvals, with public health authorities only picking up the slack in rare examples. But the result is that we have not built a system that would make studies simpler; most patients have little opportunity to participate in research; and we are too slow to figure out what works.
What would the system look like if we fixed it? It would make it easier to study drugs for heart disease, where studies are so large and expensive that many companies don’t test their medicines. It would ease studies for rare cancers, which are currently problematic because the right patients are hard to find. And it could create a medical information superhighway that would power health care through the next century.
That is from Matthew Herper in StatNews. Via Malinga Fernando.