{"id":56675,"date":"2015-05-07T18:11:02","date_gmt":"2015-05-07T22:11:02","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=56675"},"modified":"2015-05-07T18:12:19","modified_gmt":"2015-05-07T22:12:19","slug":"zero-tolerance","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/05\/07\/zero-tolerance\/","title":{"rendered":"zero tolerance…"},"content":{"rendered":"\n

In the process of being involved in an in depth reanalysis of a Clinical Trial with full access to the raw data is that far and away, the most important deterrent to bias is strict adherence to the a priori <\/em>Protocol as approved by the Institutional Review Board before commencing the study. A properly constructed Protocol covers all the bases before the batter even enters the box. It should be even possible to pre-program the analysis of the results prior to starting the study. Once you see the results, or even get a whiff of the results, Old Man Bias raises his ugly head whether you know it or not. I’m beginning to think the same thing about financial conflicts of interest. There’s a new article in the New England Journal that suggests that we’re too paranoid about industry misconduct these days, and jumping to conclusions [Reconnecting the Dots — Reinterpreting Industry–Physician Relations<\/a>]. It feels like a biased report to me, designed to bring me around to a more tolerant position, but it had the opposite effect – pushing me in the direction of zero tolerance<\/font><\/strong><\/em>.<\/p>\n

I recently reviewed two articles [both published ahead of print] on Brexpipradole, a new Atypical Antipsychotic apparently under review by the FDA for approval [the spice must flow…<\/em><\/a><\/a>]: <\/div>\n
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Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial<\/font><\/a><\/div>\n
by Correll CU<\/font><\/strong>, Skuban A<\/font><\/strong>, Ouyang J<\/font><\/strong>, Hobart M<\/font><\/strong>, Pfister S<\/font><\/strong>, McQuade RD<\/font><\/strong>, Nyilas M<\/font><\/strong>, Carson WH<\/font><\/strong>, Sanchez R<\/font><\/strong>, and Eriksson H.<\/font><\/strong><\/div>\n
American Journal of Psychiatry.<\/font><\/strong> 2015 Apr 16 [Epub ahead of print]<\/div>\n
[NCT01396421<\/a>] <\/div>\n<\/blockquote>\n
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A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia.<\/font><\/a><\/div>\n
by Kane JM<\/font><\/strong>, Skuban<\/font><\/strong>, Ouyang<\/font><\/strong>, Hobart, Pfister<\/font><\/strong>, McQuade<\/font><\/strong>, Nyilas<\/font><\/strong>, Carson<\/font><\/strong>, Sanchez<\/font><\/strong>, and Eriksson<\/font><\/strong>.<\/div>\n
Schizophrenia Research.<\/font><\/strong> 2015 Feb 12. [Epub ahead of print]<\/div>\n
[NCT01393613<\/a>]<\/div>\n<\/div>\n<\/blockquote>\n
I hadn’t realized it, but I have something of a protocol when I look at a Clinical Trial these days:<\/div>\n