After more than a year of haggling, European regulators have finalized guidelines for drug makers that want to redact trade secrets from published clinical trial data. And the rules are receiving a cautious reaction.
The move follows protracted debate over trial data transparency, which has been a controversial issue following several scandals over safety or effectiveness data that was not publicly shared.
For years, drug makers have argued that releasing certain data would not only compromise patient privacy, but also harm their competitive standing. Conversely, researchers have responded that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work.
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