What’s in the new EU Clinical Trial Regulation? Part 3: What does it mean for medical writers?

Posting of clinical trial summary results to the EudraCT database became mandatory on 21 Jul 2014.  These posts will feed into the publicly accessible European Union Clinical Trials Register and thus will be available to the public.  For any interventional trial in the EU that ended on or after this date, posting of results is required within 12 months after the end of the trial for most trials; results of trials in the scope of Article 46 of the Paediatric Regulation (trials conducted in children of a product with an EU marketing authorisation) must be posted within 6 months after the end of the trial.  Most sponsors have a procedure in place for posting trial results on clinicaltrials.gov but will need to modify their procedures to cover EudraCT posting and to comply with the shorter timeline for paediatric data.

The EMA will publish all clinical study reports (CSRs) that are submitted in support of a marketing authorisation application, as part of a variation, or to fulfil a postauthorisation commitment.  Publication will likely include some CSR appendices such as the protocol, the case report form, and the statistical analysis plan.  An EMA representative at a lecture I recently attended indicated that Clinical Summaries and Clinical Overviews may also be published.  The details of this process have not yet been finalised, and the EMA have postponed formal adoption of the policy until its 2 Oct 2014 meeting.  They have stated repeatedly that these requirements will become applicable in 2016 at the earliest. Nonetheless, a new term has  already entered our medial writing vocabulary to indicate the work we need to do before then.  We should start planning now for documents that are not only submission-ready but also “disclosure-ready,” that is, ready to be pored over by the general public, competitors, and—in the case of some products such as vaccines—outright opponents.

The new EU CTR introduces a new document: a summary of results for laypersons. This document will be required along with the CSR and will also be published by the EMA.  The CTR contains a list of items to be covered, but it poses a challenge to regulatory writers, to whom this task will likely fall. We need to develop strategies for communication with this new audience.  I am planning a session for the European Medical Writers Association conference in May 2015, so join us in Dublin for a lively discussion.

The new EU CTR also contains lists of required content for protocols and CSRs.  These requirements are more numerous and complex than the ICH requirements. Although there is some lag in these requirements coming into effect, sponsors and medical writers should start now to update templates and procedures to incorporate the requirements and thus avoid delays and potential rejection of applications as the transition to the new regulation occurs.

The United States FDA is also considering a policy on clinical trial data transparency. The policy was expected last month, but I have not seen anything yet. Watch this space for updates.

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