{"id":27245,"date":"2012-09-12T20:37:42","date_gmt":"2012-09-13T00:37:42","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=27245"},"modified":"2012-09-13T02:02:52","modified_gmt":"2012-09-13T06:02:52","slug":"eyes-wide-shut-open-ii","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/09\/12\/eyes-wide-shut-open-ii\/","title":{"rendered":"eyes wide <strike>shut<\/strike> open II\u2026"},"content":{"rendered":"\n<p align=\"justify\">In the last post [<strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/12\/eyes-wide-shut-open-i\/\" target=\"_blank\"><u><font color=\"#200020\">eyes wide <strike>shut<\/strike> open I&hellip;<\/font><\/u><\/a><\/strong>], I left off with the <a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT00385671?term=cymbalta&#038;rank=5&#038;sect=X3015\" target=\"_blank\"><u><strong><font color=\"#200020\">results<\/font><\/strong><\/u><\/a> from this study[<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00385671?term=cymbalta&#038;rank=5&#038;sect=X3015\" target=\"_blank\"><u><strong><font color=\"#200020\">An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain<\/font><\/strong><\/u><\/a>]. I&#8217;m not going to attempt to summarize all that&#8217;s posted [it&#8217;s easily accessed with 1-click <a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT00385671?term=cymbalta&#038;rank=5&#038;sect=X01#more\"><u><strong><font color=\"#200020\">here<\/font><\/strong><\/u><\/a>]. But here&#8217;s a sample, the posting for the Primary Outcome Measure &#8211; &quot;<em>Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine.<\/em>&quot;<\/p>\n<p align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/lyoo-5.gif\" \/><\/p>\n<p align=\"justify\">It&#8217;s pretty comprehensive. And it goes on and on:<\/p>\n<p align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"393\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/lyoo-6.gif\" \/><\/p>\n<p align=\"justify\">I&#8217;m not complaining here. This kind of result reporting surely would&#8217;ve deterred Sally Laden and the authors of Study 329 from publishing their Paxil Study in such a deceitful way [or at all]. But, for once, I have a sympathetic thought for the pharmaceutical manufacturers. Looking at all this information so nicely formatted, I can understand why they give them a year to post it, and and at least some of the reason why they are so regularly delinquent [<strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/09\/bring-on-the-hoops\/\"><u><font color=\"#200020\">bring on the hoops! [at least the ones that matter]&hellip;<\/font><\/u><\/a><\/strong>]:<\/p>\n<p align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"291\" height=\"201\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ct-1.gif\" \/><\/p>\n<div>This is what <strong><font color=\"#200020\">ClinicalTrials.gov<\/font><\/strong> has to say about the Results Database:   <\/div>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/beta\/about-site\/results\"><sup><u><strong><font color=\"#200020\">What Is the Results Database?<\/font><\/strong><\/u><\/sup><\/a><\/div>\n<p>    <\/p>\n<div><sup>The ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the <a href=\"http:\/\/frwebgate.access.gpo.gov\/cgi-bin\/getdoc.cgi?dbname=110_cong_public_laws&#038;docid=f:publ085.110.pdf#page=82\" title=\"FDAAA 801 - PDF opens new window\">Food and Drug Administration Amendments Act of 2007 (FDAAA 801)<\/a>, which requires the submission of &quot;basic results&quot; for certain clinical trials, generally not later than one year after the Completion Date (see <a href=\"http:\/\/prsinfo.clinicaltrials.gov\/definitions.html#PrimaryCompletionDate\" title=\"Protocol Data Element Definitions - opens new window\">Primary Completion Date data element<\/a>  on ClinicalTrials.gov.) Submission of adverse event information was optional when the results  database was released and became required in September 2009.  Results  information for registered and completed studies is submitted by the  study sponsor or principal investigator in a standard, tabular format  without discussions or conclusions. <strong><font color=\"#990000\">The information is considered  summary information and does not include patient-level data.<\/font><\/strong> The results  information that is submitted includes the following:<\/sup><\/div>\n<ul><sup>     <\/p>\n<li>\n<div align=\"justify\"><strong>Participant Flow.<\/strong>  A tabular summary of the progress of participants through each stage of  a study, by study arm or comparison group. It includes the numbers of  participants who started, completed, and dropped out of each period of  the study, based on the sequence in which interventions were assigned.  \t\t<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong>Baseline Characteristics.<\/strong>  A tabular summary of the data collected at the beginning of a study for  all participants, by study arm or comparison group. These data include  demographics, such as age and gender, and study-specific measures (for  example, systolic blood pressure, prior antidepressant treatment). \t\t<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong>Outcome Measures and Statistical Analyses.<\/strong> A tabular summary of <a href=\"http:\/\/clinicaltrials.gov\/beta\/help\/glossary\/outcome-measure\" title=\"'Outcome Measure' definition - opens new window\">outcome measure<\/a>  values, by study arm or comparison group. It includes tables for each  prespecified primary and secondary outcome and may also include other  prespecified outcomes, post hoc outcomes, and any appropriate  statistical analyses. \t\t<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong>Adverse Events.<\/strong> A tabular summary of all anticipated and unanticipated  <a href=\"http:\/\/clinicaltrials.gov\/beta\/help\/glossary\/serious-adverse-event\" title=\"'Serious Adverse Event' definition - opens new window\">serious adverse events<\/a> and a tabular summary of anticipated and unanticipated <a href=\"http:\/\/clinicaltrials.gov\/beta\/help\/glossary\/other-adverse-event\" title=\"'Other Adverse Event' definition - opens new window\">other adverse events<\/a>  exceeding a specific frequency threshold. For each serious or other  adverse event, it includes the adverse event term, affected organ  system, number of participants at risk, and number of participants  affected, by study arm or comparison group. \t\t<\/div>\n<\/li>\n<p>     <\/sup><\/ul>\n<div><sup>ClinicalTrials.gov staff review results submissions to ensure  that they are clear and informative prior to posting to the Web site.  However, ClinicalTrials.gov cannot ensure scientific accuracy. Data  providers are responsible for ensuring that submitted information is  accurate and complete.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">It&#8217;s a tall order, and I presume with the <strong><font color=\"#200020\">TEST Act<\/font><\/strong> requiring more studies publish results, that there will be greater compliance and enforcement. But I can see how once the study is over, it would be easy to move on to other things and procrastinate about putting together a Results Report like this. But there are a couple of other considerations that occur to me as I think through the long-wished-for future of data transparency:<\/div>\n<ul>\n<li>\n<div align=\"justify\">I&#8217;m opposed to senseless bureaucracy. If they&#8217;re going to be required to publish their data, I want to make it as easy as possible for them to do it. The format above doesn&#8217;t look easy. <\/div>\n<\/li>\n<li>\n<div align=\"justify\">This is not really <strong><font color=\"#200020\">raw data<\/font><\/strong> [&quot;<em>The information is considered  summary information and does not include patient-level data.<\/em>&quot;]. It&#8217;s Means and Standard Deviations, Statistical Comparisons. Those are certainly interesting and standard fare, but frankly, I want to see the individual subject data. I trust it more, and it would be required if, for example, I wanted to do a meta-analysis [or check somebody else&#8217;s meta-analysis]. I don&#8217;t trust them not to find a way to hide behind the stats just like they&#8217;ve done for years. <\/div>\n<\/li>\n<li>\n<div align=\"justify\">I don&#8217;t want to wait. If I read an article that feels jury-rigged, I  want to go to the primary data immediately to see if I&#8217;m right, or just  being too hypervigilant. And any teacher will tell you that you get students to hand in their work before you turn in their grades or give them credit. That&#8217;s how you assure that the dog won&#8217;t eat their homework. That why I want the results posted as a requirement for either consideration for publication or application for FDA Approval. I want peer reviewers to have access if they want to take a look. I want it there for critical readers to take a look. I want to take a look&#8230; <\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">In the next post, I&#8217;m going to give an example of really <strong><font color=\"#200020\">raw data<\/font><\/strong>, and an example where the kind of reporting used in <strong><font color=\"#200020\">ClinicalTrials.gov<\/font><\/strong> might get in the way&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In the last post [eyes wide shut open I&hellip;], I left off with the results from this study[An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain]. I&#8217;m not going to attempt to summarize all that&#8217;s posted [it&#8217;s easily accessed with 1-click here]. But here&#8217;s a sample, the posting [&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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-27245","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/27245","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=27245"}],"version-history":[{"count":19,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/27245\/revisions"}],"predecessor-version":[{"id":27284,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/27245\/revisions\/27284"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=27245"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=27245"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=27245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}