AllTrials campaigners condemn today’s interim court decision to order the European Medicines Agency not to release Clinical Study Reports submitted by companies as part of marketing authorisation for medicines. This ruling was made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune, who challenged the Agency’s decisions to grant access to the information.
Vitally important information about clinical trials on medicines being taken by patients all over Europe is routinely being withheld from doctors and patients. The Clinical Study Reports that were briefly made available by the European Medicines Agency (EMA) were one of the few ways that researchers could access withheld material.
There is no justification for withholding information about the methods and results of clinical trials from doctors, researchers, payers and patients, who need all the information on a medicine to make truly informed decisions. The EMA is charged with protecting patients: they should be allowed to work with researchers to improve the safety and effectiveness of everyday medical decisions. Forcing them to hide this information is nothing short of absurd.
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