{"id":31262,"date":"2012-08-24T09:40:01","date_gmt":"2012-08-24T13:40:01","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=31262"},"modified":"2012-08-24T21:29:52","modified_gmt":"2012-08-25T01:29:52","slug":"topol-the-clinical-trial-world-is-contrived","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/08\/24\/topol-the-clinical-trial-world-is-contrived\/","title":{"rendered":"Topol: The Clinical Trial World Is \u201cContrived\u201d"},"content":{"rendered":"

I was intrigued by an email that touted a piece by\u00a0Eric Topol. The startling headline: \u201cGet Rid of the Randomized Trial.\u201d<\/a> Eric is one of the pioneers of the large, simple\u00a0randomized trial\u00a0and 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.<\/p>\n

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.\u00a0He describes a trial using crenezumab, to prevent Alzheimer\u2019s disease in high-risk individuals, that depends on surrogate endpoints. He says that these are the trials of the future \u2014 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.<\/p>\n

Then he says what we need is surveillance of every patient in a trial \u2014 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 \u201ccontrived clinical trial environment\u201d and says we \u201cneed to get to the real world.\u201d<\/p>\n

Because it is Eric Topol presenting this argument, this piece on Medscape\u00a0is worth a viewing<\/a>. It would be a big change to approve first and evaluate later \u2014 and to get rid of the randomized trial.<\/p>\n

What\u2019s your view of Topol\u2019s proposal?<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Eric Topol says it’s time to “get rid of the randomized trial.” What do you say?<\/p>\n","protected":false},"author":211,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[619,1422,1421,1420],"class_list":["post-31262","post","type-post","status-publish","format-standard","hentry","category-general","tag-alzheimers-disease-2","tag-crenezumab","tag-eric-topol","tag-randomized-trials"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31262","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/211"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=31262"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31262\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31262"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31262"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31262"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}