Publication deferral: a choice to be made promptly
One of the critical aspects of the sponsors’ activities in the Clinical Trial Information System (CTIS) is the possibility of deferring the publication of clinical trials documents for a given time, depending on the trial category. This choice must be made when the Clinical Trial Application (CTA) is submitted to EMA. The following comment provides in-depth information on the deferral procedure and its added value for sponsors.
While CTIS requires sponsors to submit two versions of almost all trial documents “for publication” and “not for publication,” their content does not have to be vastly different in each case. Much will depend on the contents of the document. If, for example, the document does not contain any personal data, sponsors can submit the same version for regulatory review and publication. For managing commercial confidential information (CCI) in the version to be made public, “sponsors do not have to redact everything because they can apply to delay its publication,” an EMA officer said.
The deferral mechanism is a tool for companies to reduce their burden of redacting CCI from making public documents. To help CTIS users make the best use of this tool, the EMA is developing guidance to help them “better understand what should be redacted in terms of personal data and CCI in conjunction with the use of deferral mechanism.” The guidance is expected to be published in the first quarter of this year.
The EMA officer also suggested that sponsors should review their trial documentation templates to ensure these do not capture information that is not needed. Some companies have already embarked on this exercise. The aim should be to develop high-quality trial documents to support regulatory evaluation, especially since the CTR has strict timelines for responding to RFIs.
It will not be possible for sponsors to change these critical decisions later. If, for example, no deferral request is made when submitting an initial application, then all the documents/data will be made public as soon as a decision is taken on the trial application.
In the case of multi-state trials, the documents/data will be made public “as soon as the first member state concerned has issued a decision,” regardless of whether the reporting member state is still reviewing the trial, EMA clarified.
The deferral settings must be agreed in the beginning. While assessing an initial application, the reporting member state (in consultation with concerned member states) can request information (RFI) on the deferral timelines the sponsor proposes if, for example, “they consider it too long a period.” In such cases, “the sponsor with an RFI can modify the deferral setting,” but once a trial is authorized, “then the deferral settings as defined are set,” she added.
In the case of Category 1 trials (e.g., Phase I, first-in-human), however, if the sponsor asks to delay the publication of the main characteristics of the trial, there is an additional box in CTIS for justifying the deferral. This justification will be published together with the investigator brochure.
According to EMA, approximately 100 sponsor organizations have received access to the CTIS training environment to date. The test environment is available for use even after CTIS go-live. Additional sponsor organizations may be granted access to the training environment. The EMA has also developed an extensive online modular training program and a sponsor handbook to help sponsors prepare.