{"id":52755,"date":"2015-01-01T19:29:47","date_gmt":"2015-01-02T00:29:47","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=52755"},"modified":"2015-01-01T21:21:55","modified_gmt":"2015-01-02T02:21:55","slug":"why-data-transparency-iii","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/01\/01\/why-data-transparency-iii\/","title":{"rendered":"why data transparency? III\u2026"},"content":{"rendered":"\n<p align=\"justify\" class=\"small\">I looked at the ClinicalTrials.gov Results Database several years ago, and decided it was an improvement over just having the published paper because of its strucyure, but was far short of having the raw data&nbsp; [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/12\/eyes-wide-shut-open-i\/\" target=\"_blank\">eyes wide <strike>shut<\/strike> open I&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/12\/eyes-wide-shut-open-ii\/\" target=\"_blank\">eyes wide <strike>shut<\/strike> open II&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/13\/eyes-wide-shut-open-iii\/\" target=\"_blank\">eyes wide <strike>shut<\/strike> open III&hellip;<\/a>, and <a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/13\/eyes-wide-shut-open-iv\/\" target=\"_blank\">eyes wide <strike>shut<\/strike> open IV&hellip;<\/a>]. But I have to say that it&#8217;s far more helpful to have it than not. And using it, you can get closer to knowing if you can trust the published article. So I&#8217;m all for Dr. Collins&#8217; proposal to make it really non-optional, turning it into what it was intended to be [<a target=\"_blank\" href=\"http:\/\/directorsblog.nih.gov\/2014\/11\/19\/honoring-our-promise-clinical-trial-data-sharing-2\/\">Honoring Our Promise: Clinical Trial Data Sharing<\/a> and see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2014\/11\/23\/promises-promises\/\">promises, promises&hellip;<\/a>].<\/p>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"449\" height=\"37\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/lyoo-7.gif\" \/><\/div>\n<div align=\"justify\" class=\"small\">I&#8217;m not going through the <font color=\"#200020\">Results Section<\/font> in detail for this study. It&#8217;s there for your perusal. In this case, there&#8217;s not much substantial differences between it and the paper. My contention would be that&#8217;s because it&#8217;s there. But look it over. It&#8217;s self explanatory. There&#8217;s nothing that makes all the site jockeying any clearer. Here&#8217;s the punch line as far as I&#8217;m concerned. First, from the paper:<\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><em><font color=\"#2000230\"><u>Weight and vital signs<\/u>. Mean baseline-to-endpoint weight change [LOCF] was significantly greater for OFCtreated patients [4.4 kg, standard error [SE]=0.2] than placebo-treated patients [0.5 kg, SE=0.3; p&lt;.001]. Using MMRM methodology to model expected weight gain if all patients completed the 8-week study, mean weight change from baseline to week 8 was 5.1 kg [SE=0.3] for OFC-treated versus 0.6 kg [SE=0.4] for placebo-treated patients [p&lt;.001]. Baseline-to-endpoint mean change in body mass index was also significantly greater for the OFC group [1.5 kg\/m2, SE=0.1] than the placebo group [0.1 kg\/m2, SE=0.1; p&lt;.001]. Incidence of gaining &ge;7% of baseline body weight was significantly greater for the OFC group relative to placebo [52% vs. 4%, p&lt;.001], as was incidence of gaining &ge;15% of baseline body weight [14% vs. 0%, p&lt;.001]. No placebo patients and 2 OFC-treated patients gained &ge;25% of their baseline.<\/font><\/em><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">Then from the ClinicalTrials.gov database:  <\/div>\n<div align=\"center\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"449\" vspace=\"7\" height=\"181\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ofc-2.gif\" \/><\/div>\n<div align=\"justify\" class=\"small\">I&#8217;m not sure I would want to prescribe a 10+ pound mean weight gain over two months in return for the statistical but not very large gain in efficacy.<\/div>\n<div align=\"center\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"245\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ofc-4.gif\" \/><\/div>\n<div align=\"justify\" class=\"small\">And then there&#8217;s this, meaning they just made it under the wire with their guest author: <\/div>\n<div align=\"center\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" vspace=\"7\" height=\"181\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ofc-3.gif\" \/><\/div>\n<div align=\"justify\" class=\"small\">As I said, I&#8217;m not contesting this study, but the ClinicalTrials,gov Results Database keeps them honest. For example, it&#8217;s easy to check out something like the stats on total aggressive acts in the SAEs.<\/div>\n<div align=\"center\" class=\"small\"><img decoding=\"async\" vspace=\"7\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ofc-6.gif\" \/><\/div>\n<div align=\"justify\" class=\"small\">If we had <font color=\"#200020\">the <em>a priori<\/em> Protocol<\/font>, <font color=\"#200020\">accurate information about the CRO that did the study<\/font>, <font color=\"#200020\">the true story about the sites used<\/font>,<font color=\"#200020\"> the completed ClinicalTrials.gov Results Database<\/font>,<font color=\"#200020\"> and the FDA NDA [New Drug Approval] Medical Report<\/font>, we could actually do a decent job of vetting these Clinical Trial articles. <em><strong><font color=\"#200020\">But if we found something suspicious, we&#8217;d still need access to the raw data &#8211; Individualized Participant Data [IPDs] and perhaps the Client Report Forms [CRFs] &#8211; to actually run down any problems found.<\/font><\/strong><\/em>   <\/div>\n<p align=\"center\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"341\" height=\"252\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/clinical-trial-6.gif\" \/><\/p>\n<p align=\"justify\" class=\"small\">It sounds like a lot of hoops to make the trialists jump through, but it&#8217;s not. All of that information is already available. It would probably take them less time to put all that stuff up than it took me to write these three blogs. The pharmaceutical companies don&#8217;t want to do that because they want to be able to continue to <em>accent the positive and eliminate the negative<\/em>. And if they continue to act like they&#8217;ve acted in the last couple of decades, they&#8217;re going to lose the right to test their own products. Disease treatment is between the medical profession and our patients, not a playground for entrepreneurship and scientific deceit.<\/p>\n<div align=\"justify\" class=\"small\">And as for <font color=\"#200020\">Symbiax&reg;<\/font>, who needs it? no matter what the trial says. It&#8217;s a patent extending experimercial to treat a questionable disorder. And even if you do use it, as Dr. Varner <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/01\/01\/why-data-transparency-ii\/#comment-260728\">pointed out<\/a>, it costs $130\/month more to take one pill a day instead of two. I&#8217;d like to thank Dr. DelBello and Eli Lilly for producing this fine example for my comments on Dr. Collins&#8217; proposals. I hope that the JAACAP learns somewhere down the line that a ghost-written industry study with a guest author is still just an industry study, with all the conflict of interest problems that kept such studies out of our peer reviewed journals in our more scientifically honest past. Shame on Eli Lily and shame on the JAACAP&#8230;<font color=\"#200020\"><br \/>  <\/font><\/div>\n","protected":false},"excerpt":{"rendered":"<p>I looked at the ClinicalTrials.gov Results Database several years ago, and decided it was an improvement over just having the published paper because of its strucyure, but was far short of having the raw data&nbsp; [see eyes wide shut open I&hellip;, eyes wide shut open II&hellip;, eyes wide shut open III&hellip;, and eyes wide shut [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-52755","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/52755","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=52755"}],"version-history":[{"count":30,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/52755\/revisions"}],"predecessor-version":[{"id":52790,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/52755\/revisions\/52790"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=52755"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=52755"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=52755"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}