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EU watchdog raps EMA for redacted AbbVie data

Issues over the redaction of clinical study reports

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European Ombudsman Emily O'Reilly has taken issue with the EMA over the redaction of clinical study reports (CSRs) for AbbVie's Humira.

After reviewing the original and redacted versions, O'Reilly has asked the regulator to explain why some details were blacked out in CSRs requested by an independent researcher, saying in a letter to EMA Executive Director Guido Rasi she has "doubts and concerns" about their legality.

The Humira (adalimumab) CSRs have been at the centre of a legal dispute between AbbVie and the EMA, with the company suing the regulator last year to try to keep details hidden.  As part of a settlement agreement in April the EMA agreed to redact some of the information, prompting the Ombudsman's enquiry.

In the letter, O'Reilly notes that some redactions were clearly justified as they pertained to personal data of patients while others relating to companies providing services to AbbVie are also legitimate as they "may be considered to relate to the confidential business relationships."

She is unhappy about others, however, such as the redaction of a section explaining the rationale for Humira dose selection because of an unspecified "ongoing development" and asks whether the EMA is aware of this development or has simply relied on the company's "unsubstantiated assertion."

Other problematic redactions - 16 in total - relate to sections covering the determinations of sample, protocol and statistical changes, statistical methods, secondary endpoints in trials and lot numbers, among others.

The Ombudsman asked for a reply to her letter by January 31 2015, but the EMA was quick to publish preliminary feedback on the criticism, adding it would send a detailed response in due course.

In a statement, it said that while there is clear guidance on what personal details should be redacted, the procedure for commercially confidential information is considerable more vague.

The agency now finds itself between a rock and hard place, with the terms of its lawsuit settlement on one side and the Ombudsman on the other, and how the EMA navigates between the two will likely have implications on the interpretation of clinical trial transparency policy in Europe.

The EMA revealed its policy on publishing clinical trial results last month, but drew immediate criticism from organisations such as the AllTrials transparency pressure group for a number of elements contained in the document, including the redactions process.

"Stakeholder feedback and experience continue to shape EMA's understanding of commercially confidential information," said the agency in its response to O'Reilly's letter, although it points out that it "is responsible for ruling on any redactions of documents to be published."

"Based on experience and stakeholder feedback, the agency is continuously improving its understanding of what can and cannot be considered confidential," it added.

Article by
Phil Taylor

14th November 2014

From: Regulatory



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