Clinical Trials Transparency: EMA Delay Gives Industry Initiative More Time To Take Root
This article was originally published in The Pink Sheet Daily
EMA’s plans for access to clinical trials data not set to be ready until well into 2014.
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In finalizing its policy on publishing clinical study reports, EMA stresses redactions of commercially confidential information will be rare, but critics still say it is favoring the pharma industry.
Giving independent researchers access to patient-level data and requiring public release of clinical study reports would help to offset the weakening of FDA’s oversight caused by industry’s First Amendment victories, a Boston University professor says.
AbbVie’s decision to drop two cases against the EMA is likely to boost clinical trial transparency as well as bring drug regulators and the industry closer to a joint definition of commercial confidentiality.