Confidentiality of clinical trials information could be maintained if relevant to chain of research, EMA proposes's bookmarks 2015-01-29


"The EMA has launched a consultation (28-page / 278KB PDF) on proposals which would flesh out more detail on what information pharmaceutical companies and other medical researchers would need to publish on a new publically-accessible database, as well as the timings of those disclosures, under the EU's new Clinical Trials Regulation. The EMA is responsible for developing and maintaining the database under the new framework.  The Regulation sets new standards on transparency for clinical trials conducted in the EU. The framework, which was finalised last year, is scheduled to be applied to new clinical trial tests beginning on or after 28 May 2016.  Information to be disclosed via the database under the new regime will include descriptions about the kind of trials being conducted and a summary of the results, whilst clinical study reports will also have to be published after medicines have been approved for sale.  However, there are some exceptions to the disclosure requirements. One exception is where information about clinical trials is 'commercially confidential' and where there is not an overriding public interest in its disclosure.  The EMA said that 'commercially confidential information' under the new EU clinical trials rules, should be defined as 'any information contained in the data or documents submitted to the database that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the sponsor' ..."


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oa.biomedicine oa.medicine oa.policies oa.clinical_trials oa.europe oa.ema oa.consultations ru.sparc15 oa.pharma

Date tagged:

01/29/2015, 08:52

Date published:

01/29/2015, 10:49