AllTrials – Should the EMA be allowed to censor independent analysis of side effect data?

abernard102@gmail.com 2014-08-10

Summary:

"The European body which oversees the collection of information on side effects of drugs wants to have the right to censor reporting of independent analysis of this information if it doesn’t agree with the analysis. The European Medicines Agency oversees the EudraVigilance database where reports of side effects from approved drugs in Europe are recorded. Some of the reports on the database are directly reported by doctors and patients. Researchers can currently request access to some of this information. The database also contains detailed reports of side effects that occur during clinical trials run in Europe. On Monday the EMA published a proposal to give researchers access to these detailed and systematic records. However, the EMA has a number of conditions that researchers have to agree to access any of this data ... Since AllTrials began nine global companies have agreed to greater transparency than the European regulator is proposing. This regulation would be out of date before it begins.  The European Medicines Agency wants to hear what you think of this new policy. The consultation is open until 15th September 2014 ..."

Link:

http://www.alltrials.net/news/should-the-ema-be-allowed-to-censor-independent-analysis-of-side-effect-data/

From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com
Open Access Tracking Project (OATP) » pontika.nancy@gmail.com's bookmarks

Tags:

oa.policies oa.europe oa.ema oa.data oa.clinical_trials oa.pharma oa.lay oa.advocacy oa.alltrials oa.consultations oa.comment oa.new ru.sparc

Date tagged:

08/10/2014, 07:36

Date published:

08/10/2014, 09:18