CCI: why it is better not to include them in the Clinical Study Report

confidentialThe safest way for drug companies to ensure the European Medicines Agency does not publish commercially confidential information that they believe their clinical study reports might contain is to not include the information in the first place.

In the first year of the policy going live, the EMA rejected 76% of the proposals companies made on redacting CCI. (Also see “EMA Rejects 76% Of Requests To Label Info In Clinical Reports As Commercially Confidential”  – Pink Sheet, 13 Feb, 2018.)

The recommendation is based upon the evidence mentioned above, has been addressed for the first time by Steve Bamford, Head of Data Transparency – Janssen, during his presentation at the DIA Europe Congress that took place in Basel last April. Neena Brizmohun has further deepened it in the article Protecting CCI And Partnership Submissions For EMA’s Clinical Data Publication Policy, posted on the Pink Sheet 5 June.

Thanks to Robert Paarlberg, chair of the Clinical Trial Disclosure Community – DIA, for bringing this to our attention.