Redacted policy on sharing drug trial data in Europe | BMJ

Use the link to access the full text article published in BMJ.  An excerpt reads as follows: "In early April, the drug company AbbVie dropped its lawsuit against the European Medicines Agency (EMA). This lawsuit, along with another case mounted by InterMune, delayed the agency’s plans to release previously hidden clinical trial data about drugs considered for marketing authorisation.1 It also posed such a threat to public health that The BMJ and BMA were jointly granted permission to intervene at the General Court of the European Union.2 3 AbbVie withdrew its case after the agency agreed to allow redaction of some clinical trial information deemed to be commercially sensitive.4 Now, shortly before the EMA’s policy is to be set in stone, we know the extent of that compromise. Documents shared with participants at a recent EMA workshop suggest that the agency is backtracking both on its principle of public access to clinical trial data 'in an analysable format' and its assertion that 'in general, clinical trial data cannot be considered commercially confidential information (CCI)' because 'the interests of public health outweigh considerations of CCI.'1 Instead, clinical study reports (CSRs) and other detailed information will be available only to registered users, and only through 'controlled access' and in a 'view on screen only' mode. Furthermore, some information—even details of study designs, statistical analyses, and study results—could be redacted if study sponsors deem it to be commercially confidential.5 There are just a few days left to voice concerns about this—the agency’s management board meets on 12 June to finalise the policy. The authors of the first ever Cochrane reviews using clinical study reports are aghast.6 ..."