{"id":46537,"date":"2014-05-25T14:46:19","date_gmt":"2014-05-25T18:46:19","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=46537"},"modified":"2014-05-25T21:08:50","modified_gmt":"2014-05-26T01:08:50","slug":"a-decision-to-reconsider","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/05\/25\/a-decision-to-reconsider\/","title":{"rendered":"a decision to reconsider…"},"content":{"rendered":"
Reading and rereading the response of the European Medicines Agency<\/a> to the European Ombudsman<\/font><\/strong> posted in to be continued…<\/a>, I can only conclude that someone has done a powerful sales job about what they call the view-on-screen-only<\/em> system [a self contained "remote desktop"] – selling it as something it neither is nor can become. <\/div>\n

As I said earlier [the end game…<\/a>], as a member of the RIAT team who was granted access to the Data from Paxil Study 329 to do an independent reanalysis by GSK, we’ve now had months of experience working with their "remote desktop" interface as a portal to their information. It is a single windowed multiple document interface, totally self contained that can’t be accessed by any software other than that provided inside the window. Multiple passwords are required multiple times for access, and on some days, one is frequently thrown from the system without warning, necessitating repeated logins. There’s another internal window from SAS that contains the data and allows one to run SAS programs to analyze the data. The data is also provided as text-based CSV files that can be moved outside the internal SAS window and displayed in spreadsheets [Open Office is provided]. The open source statistical program, "R" is also provided. In our case having no-one fluent in SAS procedures and programming, we are using "R" which has the necessary statistical functions. Getting the data into the proper format required by "R" means using multiple spreadsheets – which is very difficult in the cramped space provided – sometimes taking days and involving many "start-overs." Once the data is analyzed, one can only export non-data containing files with results, and that’s only by application for approval. Using the primitive graphing functions of Open Office or "R’ in the "remote desktop" is very difficult and the graphs can’t be exported. That finally lead us to copy the information for the graphs by hand to get it into the computer proper to create our images. The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task.<\/p>\n

The original hand written CRFs are provided as PDF documents. In our case, there are some 275 subjects, many with several pdfs, each pdf containing 200+pages. In the interface provided, we can see only one page at a time of the nearly 60,000 pages. Tallying the adverse events from the pdfs is hard enough work, but doing to without being able to make printed copies and referring back and forth is a double nightmare, requiring days of wasted time, and delegation is impossible. Working inside of this little window brings home how important it is to have a workspace that allows simultaneous display of lots of information, and this isn’t it. One of our team has lost one assistant already over this interface. The EMA’s decision to even consider using this kind of interface is at best, ill advised, and a negation of the initial promise of Data Transparency. If I weren’t retired and instead had a job to do, I don’t think I could do it. If I were a graduate student given the task, I might go to the chairman of the department and ask for another major professor. It’s impossible to imagine that anyone contemplating this decision who knows the ins and outs of data analysis has tried it out in this kind of environment. As I said before, it’s like going to sea to see the world in a submarine, looking through a periscope. <\/p>\n

I expect the EMA means well, and may think that since the data is available in this system, it should be okay.. But they apparently don’t realize the practical burden that it inflicts on anyone trying to have a serious look at a clinical trial. At the least, I would hope they would sit someone down in front of a computer using such a system so they can see with hands-on what I’m talking about – that I’m not being melodramatic. <\/div>\n","protected":false},"excerpt":{"rendered":"

Reading and rereading the response of the European Medicines Agency to the European Ombudsman posted in to be continued…, I can only conclude that someone has done a powerful sales job about what they call the view-on-screen-only system [a self contained "remote desktop"] – selling it as something it neither is nor can become. As […]<\/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-46537","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46537","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=46537"}],"version-history":[{"count":10,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46537\/revisions"}],"predecessor-version":[{"id":46548,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46537\/revisions\/46548"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=46537"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=46537"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=46537"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}