What You Need to Know About Upcoming EU Trial Transparency Exceptions

Apr 05, 2016

Post by Adam Curran

As I outlined in a previous blog post, the new EU clinical trials regulation, which aims to resolve the issues associated with the existing EU Clinical Trials Directive and streamline the clinical trial authorization and harmonize requirements for clinical trials in Europe, is expected to come into force in 2017. I recently read an excellent article written by SCRIP Regulatory Affairs on the topic of EMA explaining its thinking on exceptions to trial transparency.

The EMA has recently provided some exceptions to trial transparency in order to protect personal data, commercially confidential information, confidential communications among member states, and information that may “protect the supervision of clinical trials by member states”. They have also provided explanations as to why these exceptions were made.

The Clinical Trial Regulation (CTR) outlines the mandatory information that should be provided on each clinical trial. Data in the clinical study report should not be considered commercially confidential, and therefore companies need to be selective in what they publish. Clearly companies want to be careful about what they disclose.

According to the Appendix on disclosure rules, signed off on the 5th October, there should be no personal subject data in the database. Raw data such as this is not permitted to be in the database or to be made public. The exceptions are to provide a “correct balance that respects both the patients’ and public’s entitlement to extensive and timely information on clinical trials, and developers’ and researchers’ need to benefit from investments, thus enhancing the EU as a destination for innovative, cutting edge research and development of novel products and research into new and better uses of existing products”.

In other words, the exceptions are put in place to ensure that both parties mutually benefit from disclosing information. However, the controversial issue about what companies exactly consider commercially confidential information is a little more complicated. The appendix states the consideration of what is considered CCI will be based on what the trial is about and the status of the IMP being studied. Although the CCI is to be respected, public interest in disclosure plays a significant role in this equation. “The extent of information made public will be timed differentially according to the use of the IMPs in the clinical trial in relation to the marketing authorization status of the indications, pharmaceutical forms and routes of administration being investigated”.

The timing of disclosure will be based on key milestones identified in the CTR:

The end of the trial
The decision on the trial
12 months after the end of the trial
“…standardized release of data and documents, which is set up to seven years after the end of the trial for category 1 trials and up to 5 years after the end of the trial for category 2 trials” (appendix)

This length of time was decided as appropriate as it ensures investigator brochures and IMPDs can be submitted to the EU portal, giving sponsors enough time before their publication to protect their economic interest. According to the appendix, five years has been taken as mid-point in the average development time of a new medicine which is generally considered to be about 10 years, and seven years is used for category 1 trials as they often start earlier in development and are generally shorter in duration.