We have been looking closely at the EMA requirements for publishing clinical data under Policy 0070. There is an expanding body of guidance, Q&As, minutes from expert groups, templates. These are very helpful to an MA applicant navigating your way through the technical requirements for the first time. Sadly, there is no shortcut to delving deep in to the material and ensuring that all the members of your team understand not only the publication requirements, timetable and formats, but also the rationale behind the policy and the approaches you adopt.
Although there are delays in publication of clinical data on the EMA Clinical Data Website, you need to be considering these publication requirements in tandem with preparing your MAA. The policy is still in Phase 1 of its implementation (publication of clinical reports not individual patient data).
Some issues to consider at an early stage include:
- the different anonymisation approaches and techniques you could use and the rationale and criteria for adopting a particular approach. In particular, consider the potential impact on data utility and how the anonymisation approach you adopt can best be defended.
- Identify the data variables (direct and quasi identifiers) in your clinical reports which are PPD.
- Will any case narratives require anonymisation and if proposing redaction (which is less likely to be acceptable to the EMA), what are your justifications for this?
- Consider which Anonymisation Assessment Option is most appropriate for your clinical data and why.
- Review clinical reports to identify any CCI. Consider what justifications can apply and prepare detailed reasons using the Justification template
- Conduct any searches to ensure proposed CCI redactions will not be rejected on grounds of public availability or public interest.
- Depending on your regulatory timetable, could clinical data publication obligations under the EU Clinical Trial Regulation also apply?