A new draft guidance from the European Medicines Agency (EMA) defines requirements for redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS).

The guidance, designed to be a reference tool, defines CCI as any information provided in a trial application or during a trial that is “not in the public domain or publicly available” and could be damaging to sponsors’ competitive positions or business interests if shared.

CTIS users should have a strong grasp of what information related to the development of the investigational product is already in the public domain, such as study design, development plan timelines and results, as well as on scientific knowledge and progress in the relevant therapeutic area, when redacting.

The agency advises sponsors to limit redactions only to the text and figures that are identified as CCI and avoid redactions of entire pages, subsections or full tables. The guidance also advises sponsors to implement a strategy to identify CCI as they write CTIS-related documentation to reduce the need for redactions and the inclusion of CCI in documents where it’s not necessary.

Read the full guidance here: https://bit.ly/3O26X0C.