Clinical Trial Regulation: Balancing Transparency Requirements and Protection of CCI – new Q&A published

The Clinical Trial Regulation (EU) No 536/2014 (CTR) became fully applicable yesterday (31 January), following the end of the transition period. Therefore, the use of the Clinical Trial Information System (CTIS) is mandatory for all new clinical trial applications as of now. Despite the long period since the CTR was adopted in 2014, several aspects, especially with regard to the transparency provisions of the CTR and their implementation, remained unclear. A new Q&A document prepared by the ACT EU initiative, led by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), was published on the website of the EMA yesterday, aiming to clarify the protection of commercially confidential information (CCI) in the European Clinical Trial Information System (CTIS).

In addition to a section on the protection of personal data, the Q&A document (s. here) focusses inter alia on the following subjects, addressing some of the industry’s concerns:

Deferrals

The Q&A clarify that there is no specific mechanism to notify sponsors in case a requested deferral is granted. However, sponsors will know that a deferral is granted if no RFIs are raised in this regard or a potential RFI has already been adequately addressed. 

The Reporting Member State (RMS) or the Member States Concerned (MSC) will in particular consider the justification for the clinical trial category (decisive for the deferral options) declared by the sponsor, but might comment on the requested deferral timelines as well. The Q&A stress the fact that multiphase or adaptive design clinical trials falling in both category 1 and 2 will be treated according to category 2, as already mentioned in the Appendix on disclosure rules document of 2015 (s. here).

Redactions

The Q&A document points out that, in general, the simultaneous use of deferrals and CCI redactions should be avoided to ensure a high level of transparency – sponsors should decide whether they would like to either redact certain information or request a publication deferral for the document concerned. However, it is acknowledged that such a simultaneous approach might be inevitable “in limited situations”. Another Q&A document of the European Commission on the Clinical Trial Regulation encourages the use of redactions in order to avoid long deferral periods and thus increase transparency (s. here, Q 6.5).

Member states might comment on the extent of the redactions, but an evaluation of all redactions conducted by the sponsor is not intended. However, member states are expected “to ensure that the principles of transparency are followed”.

Sponsors may use red border boxes to flag CCI in the “not for publication” version of the application documents. This can be a useful tool to make the assessors aware of the information classified as CCI in order to avoid the possibility that CCI is inadvertently published through RFIs or the assessment report.

Outlook

The Guidance on the protection of personal data and CCI of the EMA, which is still pending, might bring further clarity to several outstanding questions. Up to now, the EMA has only published the draft version of this guidance (s. here). However, the introduction of the new Q&A document states that this guidance will be in line with the answers in the Q&A. Nevertheless, it remains to be seen how the transparency requirements of the CTR will be implemented throughout the different member states in practice.