On Monday 15 September, two important consultations (one by the EMA and one by the FDA) will close, ending the public’s\u00a0opportunity to respond to these consultations and help\u00a0defend the independent analyses of medical data. The AllTrials campaign has been urging interested parties to respond and have their say on these two consultations, which are outlined below.<\/p>\n
Tell the EMA not to censor independent analyses<\/strong><\/p>\n In Europe, the medicines regulator wants the right to censor analyses<\/a> of side effects data that it disagrees with. The European Medicines Agency (EMA) is consulting on updates to its EudraVigilance access policy<\/a>. EudraVigilance is the database where reports of side effects from approved drugs in Europe are recorded. The proposal would give researchers access to more detailed and systematic records from the database, but it also contains a condition that would give the EMA the ability to block publication of analyses it disagreed with.<\/p>\n Read the AllTrials\u00a0response<\/a>\u00a0to this.<\/p>\n Please respond to the EMA\u2019s consultation, even with a short comment, before the deadline of Monday 15 September 2014. Feel free to use any or all of the AllTrials\u00a0response to write your own. To respond email EVAccess@ema.europa.eu<\/a>.<\/p>\n Tell the FDA not to introduce barriers to data sharing<\/strong><\/p>\n The US Food and Drug Administration (FDA) has produuced draft guidance<\/a> on writing consent forms for clinical trials, which doesn\u2019t say that trial sponsors can share anonymised patient data with independent researchers<\/a>. Some pharmaceutical companies already claim that they can\u2019t share more information from their clinical trials because consent forms didn\u2019t explicitly include this.<\/p>\n Read the AllTrials\u00a0response<\/a>\u00a0to this.<\/p>\n Please respond to the FDA\u2019s consultation, even with a short comment, before the deadline of Monday 15 September 2014. Feel free to use parts of the AllTrials\u00a0response\u00a0to write your own. Use their comment form to respond<\/a>.<\/p>\n Ian Bushfield is the campaigns support officer for the charity Sense About Science. He works mostly on the AllTrials campaign.<\/em><\/p>\n Competing interest:\u00a0I work on the AllTrials campaign.<\/p>\n This article was originally published on the AllTrials website here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" On Monday 15 September, two important consultations (one by the EMA and one by the FDA) will close, ending the public’s\u00a0opportunity to respond to these consultations and help\u00a0defend the independent analyses of medical data. The AllTrials campaign has been urging interested parties to respond and have their say on these two consultations, which are outlined […]<\/p>\n