{"id":55966,"date":"2015-04-15T12:00:28","date_gmt":"2015-04-15T16:00:28","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=55966"},"modified":"2015-05-01T18:20:23","modified_gmt":"2015-05-01T22:20:23","slug":"now-back-to-basics","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/04\/15\/now-back-to-basics\/","title":{"rendered":"now, back to basics!&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.who.int\/mediacentre\/news\/notes\/2015\/medical-research-transparency\/en\/\">WHO calls for increased transparency in medical research<\/a><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">Note for the media<\/font><\/strong><\/div>\n<div align=\"center\" class=\"small\">14 April 2015<\/div>\n<p align=\"justify\">14 APRIL 2015 | GENEVA | WHO today issued a public statement calling for the disclosure  of results from clinical trials for medical products, whatever the  result. The move aims to ensure that decisions related to the safety and  efficacy of vaccines, drugs and medical devices for use by populations  are supported by the best available evidence.<\/p>\n<p align=\"justify\">&ldquo;Our intention is to promote the sharing of scientific  knowledge in order to advance public health,&rdquo; said Dr Marie-Paule Kieny,  WHO Assistant Director-General for Health Systems and Innovation. &ldquo;It  underpins the principal goal of medical research: to serve the  betterment of humanity.&rdquo;<\/p>\n<p align=\"justify\">&ldquo;Failure to publicly disclose trial results engenders  misinformation, leading to skewed priorities for both R&amp;D and public  health interventions,&rdquo; said Dr Kieny. &ldquo;It creates indirect costs for  public and private entities, including patients themselves, who pay for  suboptimal or harmful treatments.&rdquo;<\/p>\n<div class=\"middle\"><strong><font color=\"#200020\">Unreported trials lead to misinformation<\/font><\/strong><\/div>\n<p align=\"justify\">   \t\t   \t\tFor example, in a study that analysed reporting from large  clinical trials (more than 500 participants) registered on  ClinicalTrials.gov and completed by 2009, 23% had no results reported.  These unreported trials included nearly 300 000 participants. Among  clinical trials of vaccines against 5 diseases registered in a variety  of databases between 2006-2012, only 29% had been published in a  peer-reviewed journal by the WHO recommended deadline of 24 months  following study completion.<\/p>\n<p align=\"justify\">   \t\t   \t\t&ldquo;We need the collaboration of <strong><font color=\"#990000\">all<\/font><\/strong> these actors to enforce  transparency in their jurisdictions in order to increase the benefits  and decrease the risks for patients, clinical trial volunteers and the  general public,&rdquo; concluded Dr Kieny. <\/p>\n<div class=\"middle\"><strong><font color=\"#200020\">International Clinical Trials Registry Platform furthers transparency<\/font><\/strong><\/div>\n<p align=\"justify\">   \t\t   \t\t<strong><font color=\"#990000\">WHO&rsquo;s call for disclosure includes older unreported clinical  trials<\/font><\/strong>, the results of which may still have an important bearing on  scientific research today. WHO also reaffirms the need for <strong><font color=\"#990000\">all<\/font><\/strong> clinical  trials to be registered on a WHO primary clinical trial registry so that  they can be accessible through the International Clinical Trials  Registry platform. This will ensure transparency as to which clinical  trials have occurred, and allow verification of compliance with public  disclosure requirements. <\/p>\n<div align=\"justify\">  \t\t   \t\tThe recent WHO move expands on a 2005 call for <strong><font color=\"#990000\">all<\/font><\/strong> clinical  trials to be registered, and the subsequent establishment of the  International Clinical Trials Registry Platform. This registry platform  regularly imports trial records from ClinicalTrials.gov, ISRCTN  registry, EU Clinical Trials Register, Australia New Zealand Clinical  Trial Registry, Pan African Clinical Trial Registry and Clinical Trial  Registries from China, India, Brazil, Republic of Korea, Cuba, Germany,  Iran, Japan, Sri Lanka, The Netherlands and Thailand.<\/div>\n<div align=\"right\"><strong><font color=\"#200020\">hat tip to pharmagossip&#8230;<\/font><\/strong>&nbsp; <img decoding=\"async\" height=\"35\" border=\"0\" align=\"absmiddle\" src=\"http:\/\/1boringoldman.com\/images\/hat-tip.gif\" \/>  <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">And there&#8217;s more!  <\/div>\n<ul>\n<li>\n<div align=\"justify\" class=\"small\"><a target=\"_blank\" href=\"http:\/\/www.who.int\/entity\/ictrp\/results\/WHO_Statement_results_reporting_clinical_trials.pdf?ua=1\">WHO Statement on Public Disclosure of Clinical Trial Results<\/a><\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\"><a target=\"_blank\" href=\"http:\/\/journals.plos.org\/plosmedicine\/article?id=10.1371\/journal.pmed.1001819\">Rationale for WHO&#8217;s New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results<\/a> [<a target=\"_blank\" href=\"http:\/\/journals.plos.org\/plosmedicine\/article?id=10.1371\/journal.pmed.1001819\">PLoS Medicine<\/a>]<\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\" class=\"small\">More coming after a thorough reading&#8230;<\/div>\n<hr size=\"1\" \/>\n<div align=\"justify\" class=\"small\"><strong><font color=\"#200020\">From<\/font> <font color=\"#990000\">AllTrials<\/font><\/strong>: &quot;You can read more about the WHO&rsquo;s statement and responses to it on <a target=\"_blank\" href=\"http:\/\/www.senseasdata.com\/drupal\/sites\/all\/modules\/civicrm\/extern\/url.php?u=1451&#038;qid=846191\">the AllTrials website<\/a>, in <em><a target=\"_blank\" href=\"http:\/\/www.senseasdata.com\/drupal\/sites\/all\/modules\/civicrm\/extern\/url.php?u=1452&#038;qid=846191\">Science<\/a><\/em> and <em><a target=\"_blank\" href=\"http:\/\/www.senseasdata.com\/drupal\/sites\/all\/modules\/civicrm\/extern\/url.php?u=1453&#038;qid=846191\">The Verge<\/a> <\/em>and from <a target=\"_blank\" href=\"http:\/\/www.senseasdata.com\/drupal\/sites\/all\/modules\/civicrm\/extern\/url.php?u=1454&#038;qid=846191\">Reuters<\/a>.&quot; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>WHO calls for increased transparency in medical research Note for the media 14 April 2015 14 APRIL 2015 | GENEVA | WHO today issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy [&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":[5],"tags":[],"class_list":["post-55966","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/55966","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=55966"}],"version-history":[{"count":7,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/55966\/revisions"}],"predecessor-version":[{"id":56005,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/55966\/revisions\/56005"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=55966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=55966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=55966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}