August 24th, 2012
Topol: The Clinical Trial World Is “Contrived”
I was intrigued by an email that touted a piece by Eric Topol. The startling headline: “Get Rid of the Randomized Trial.” Eric is one of the pioneers of the large, simple randomized trial and contributed many landmark studies that have shaped the practice of cardiology. His TAMI studies and GUSTO influenced so many of us who were in training during that era. Every AHA and ACC annual meeting was marked by Eric at the podium describing another important randomized trial that he had led, often with Rob Califf. So you can imagine my surprise. I skip most of these types of emails, but this title and its author compelled me to click through.
What I found was a 5-minute video of Topol making an argument that randomized trials are an anachronism and no longer fit what we need. He describes a trial using crenezumab, to prevent Alzheimer’s disease in high-risk individuals, that depends on surrogate endpoints. He says that these are the trials of the future — restricted to patients at risk and using surrogate markers. I cannot find this trial by searching for crenezumab on clinicaltrials.gov, but I assume from the press release Eric references that it is randomized.
Then he says what we need is surveillance of every patient in a trial — that we should have conditional approval of a new drug or device (without a trial?) and then monitor everyone treated. He goes on to decry the “contrived clinical trial environment” and says we “need to get to the real world.”
Because it is Eric Topol presenting this argument, this piece on Medscape is worth a viewing. It would be a big change to approve first and evaluate later — and to get rid of the randomized trial.
What’s your view of Topol’s proposal?