EMA finalizes clinical trial redaction guidelines
- The European Medicines Agency (EMA) has issued final guidance covering the publication of clinical trial data and how pharmaceutical companies can redact commercially confidential information. Pharma companies have argued releasing all clinical trail data would compromise their trade secrets, while transparency advocates and researchers have sought more complete information in order to replicate results.
- The guidance details how clinical study reports (CSRs) are to be submitted, in addition to providing an overview of what companies must do to include redactions.
- While most data-transparency advocates, including researchers who rely on CSRs to aid their research, see this as a step forward, some feel that the guidelines don't go far enough. One of the main concerns is that companies define "confidential commercial information" in too broad a way, thereby being able to withhold data which could be shared.
In October 2014, data transparency advocates in the E.U. won a victory when the EMA decided to make clinical study reports (CSRs) available to the public. Previously, CSRs had been available only on-screen without download or print functionality.
When the decision to open CSR access was made, the EMA also decided companies would have the right to protect confidential information from clinical trials. However, the group that spearheaded the transparency movement in the U.K., the AllTrials Campaign, claims companies overstate the need for confidentiality.
In a comment to STAT, Tracey Brown, head of Sense About Science, which is an AllTrials member, said, "Companies have used fear-mongering about confidentiality to create a stalemate with the European regulator. EMA’s new guidance might now put an end to that stalemate.”
In order for a company to redact data in a CSR slated for submission to the data repository, it must include a "Redaction Proposal Document," justifying why a company wants to withhold certain information.