ClinicalTrials.gov Still Lacks Many Study Results, JAMA Finds; Do Transparency Efforts Need A Boost?
Industry data transparency initiatives are well-established now, but JAMA study suggests holes in efforts to publicly release clinical trial results.
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More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron’s ‘Clerical Oversight’
‘Vast majority’ of 40 parties who received pre-notices of non-compliance with reporting requirements took action, FDA says. First noncompliance letter to Acceleron has prompted speedy response from sponsors.
Draft guidance states that "responsible parties" could be fined $10,000 for not submitting trial information to the federal data repository as required by law.
The EU General Court has dismissed three cases by pharmaceutical companies that wanted to prevent the European Medicines Agency from disclosing certain data about their marketed medicines on the grounds that it would harm their commercial interests. Firms now have a clearer idea of the standards they will need to meet to claim their information is commercially confidential.