On BMJ Blogs, Tom Jefferson updates on the latest developments and likely repercussions of European Medicines Agency policies on publicly releasing more detailed data from drug clinical trials. “The value of these documents available at the click of a button to a researcher is difficult to overplay,” writes Jefferson.
“The radical nature of the EMA’s policy lies in its offer of routine access to full clinical study reports (CSRs) with (hopefully) minimal redactions just a few days after drug approval (or rejection),” comments Jefferson. “CSRs offer us the possibility of delving into and cross checking all aspects of trials: from protocol to informed consent forms, from intended analysis methods to those which were actually used, to templates for participant data collection. Some other aspects of the policy and its implementation are revolutionary, such as access to CSRs of drugs that did not make it to the European market. The thousands of pages provide a hitherto rarely tapped bonanza of detail and the possibility to address reporting bias — the biggest threat to contemporary, ethical research synthesis.”
Tom Jefferson: The EMA revolution gathers pace (BMJ Blogs, June 30, 2015)
Tom Jefferson: Are we ready for the EMA revolution? (BMJ Blogs, June 30, 2015)
Tom Jefferson: EMA confidential—the EMA continues consultation on its 0070 policy and concerns appear (BMJ Blogs, July 9, 2015)