{"id":58173,"date":"2015-07-01T16:20:43","date_gmt":"2015-07-01T20:20:43","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=58173"},"modified":"2015-07-02T01:16:34","modified_gmt":"2015-07-02T05:16:34","slug":"a-priori","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/07\/01\/a-priori\/","title":{"rendered":"a priori<\/em>…"},"content":{"rendered":"\n

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The European Medicines Agency’s Data Transparency policy has made many twists and turns along the way – so many that I summarized them with a timeline last October to serve as a placemarker for the day when the implementation was released. That Timeline<\/font><\/a> is available for review. Tom Jefferson has reported on their recent 2+ hour<\/em> progress update Webinar<\/a> in a couple of BMJ blogs – mercifully<\/em> short and very clear. By my read, the news is good:<\/div>\n
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The EMA revolution gathers pace<\/a><\/div>\n
BMJ Blogs<\/font><\/strong><\/div>\n
by Tom Jefferson<\/div>\n
30 Jun, 15<\/div>\n
[full text on-line<\/a>]<\/div>\n<\/blockquote>\n
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Are we ready for the EMA revolution?<\/a><\/div>\n
BMJ Blogs<\/font><\/strong><\/div>\n
by Tom Jefferson<\/div>\n
30 Jun, 15<\/div>\n
[full text on-line<\/a>]<\/div>\n<\/blockquote>\n
For twenty five years, industry funded RCTs flooded the psychiatric literature, many grossly distorted – creating an illusion of safety and efficacy that produced billions of dollars in revenue for the pharmaceutical industry. There was no way to check those reports, because the actual data was a secret kept by the companies who financed the trials and sold the drugs. And so there was a major campaign to get that raw data into the public domain where it could be independently analyzed. The EMA lead the way vowing to make it available, in fits and starts, as outlined in the Timeline<\/font><\/a>. <\/div>\n

But be careful what you ask for. You might just get it. There are literally thousands of pages with each RCT. I’ve spent the last year and a half working on just one trial and it’s a maddening exercise, bouncing around in these documents looking for elusive needles among the hay. So how this data is presented and cataloged is as important as its availability. Tom’s blogs are about how the EMA is going to implement Phase I of their roll-out [the operative saying being, "the devil’s in the details"]. Here’s my monotonous graphic, updated to fit the new EMA proposals:<\/p>\n

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There are many ways to subtly distort to results of a clinical trial without committing actual fraud. The consensus is that having the raw data for a complete reanalysis is the only preventive. What are the essential pieces necessary? First, the investigator needs to specify in detail exactly how the study will be conducted; how the data will be collected; how it will be analyzed; and what criteria will be used to judge the results. All of this needs to be specified in advance. Anyone who has ever done a study knows that once you have the results, you can massage the data and make it say all sorts of things. So the PROTOCOL<\/strong> and the SAP<\/strong> [Statistical Analysis Plan] need to be prepared before the study begins [a priori<\/em>]:<\/div>\n