{"id":64622,"date":"2016-04-11T14:13:07","date_gmt":"2016-04-11T18:13:07","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=64622"},"modified":"2016-04-11T19:22:26","modified_gmt":"2016-04-11T23:22:26","slug":"the-making-of-wolf-alert-wolf-alert-part-2","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/04\/11\/the-making-of-wolf-alert-wolf-alert-part-2\/","title":{"rendered":"the making of<\/font><\/em><\/span> « wolf alert! wolf alert!… » part 2<\/font><\/em><\/span>"},"content":{"rendered":"\n

I hope I got across in the making of<\/font><\/em><\/span> « wolf alert! wolf alert!… » part 1<\/font><\/em><\/span><\/a> that I think ClinicalTrials.gov<\/font> is a good idea, and that putting it in the center of a system aiming towards appropriate Data Transparency is a good idea too, but that it needs some heavy tweaking before it will actually work. First, obviously, it needs to be used in a timely manner and that usage enforced. That part seems easy. No registration, no consideration for publication or regulatory approval. No Results posting, no consideration for publication or <\/font><\/em>regulatory <\/font><\/em>approval. No exceptions. Next, the a priori Protocol and Statistical Analysis Plan must be declared [in ClinicalTrials.gov] before the study starts and those results shown in the Results Database. If some investigator or sponsor wants to switch or add outcomes or methodologies in the published version, that’s their prerogative, but only if they also show us the results of their original plans. They can make their case in the paper, not behind closed doors<\/font><\/em>. No exceptions.<\/font><\/em>  At least that’s what I think. There are many opinions about whether the investigators should be held to their original choice of outcome variables and statistical methods. But there’s no controversy in my mind about secrecy. We need to hear what they thought a priori no matter what they decide after the study was underway or post hoc.<\/font><\/em> No exceptions.<\/font><\/em><\/font><\/em> <\/p>\n

And now for a slight change in direction, what about the actual, rather than the summary data? Here’s what others think: From the National Academy’s Institute of Medicine COMMITTEE ON STRATEGIES FOR RESPONSIBLE SHARING OF CLINICAL TRIAL DATA <\/font>come two very long policy documents…<\/div>\n