Critics Claim European Medicines Agency Wavering on Clinical Trial Transparency

Datasets from completed clinical trials offer a wealth of untapped information about patients, their underlying disease and the effects of treatments on disease pathways. In order to create such a resource for the ALS research and drug development community, Prize4Life has partnered with the NCRI at Massachusetts General Hospital to create the PRO-ACT (Pooled Resource Open-access ALS Clinical Trials) platform, the largest public ALS clinical trials dataset developed to date. In Europe, the European Medicines Agency (EMA) recently passed a law to require publication of clinical trial results to make them publically accessible (see November 2013 News). The EMA is the first major regulatory agency to pass such a law to increase transparency of clinical trial data. However, pressure from pharmaceutical companies has caused the EMA to waver on the initial proposal, according to criticism from the British Medical Journal. Where will the final policy stand? The EMA met on June 12th to finalize it, so keep your ears peeled for more soon.

Datasets from completed clinical trials offer a wealth of untapped information about patients, their underlying disease and the effects of treatments on disease pathways. In order to create such a resource for the ALS research and drug development community, Prize4Life has partnered with the NCRI at Massachusetts General Hospital to create the PRO-ACT (Pooled Resource Open-access ALS Clinical Trials) platform, the largest public ALS clinical trials dataset developed to date. In Europe, the European Medicines Agency (EMA) recently passed a law to require publication of clinical trial results to make them publically accessible (see November 2013 News). The EMA is the first major regulatory agency to pass such a law to increase transparency of clinical trial data. However, pressure from pharmaceutical companies has caused the EMA to waver on the initial proposal, according to criticism from the British Medical Journal. Where will the final policy stand? The EMA met on June 12th to finalize it, so keep your ears peeled for more soon.

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