disclosure of clinical data

Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).

Continue Reading Update on Clinical Trials Transparency in the EU

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency’s relocation will result in some areas of work being “temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard core activities”. The Agency has explained that this will mean a reduced publication of clinical data during the second half of 2018 and in 2019. However, it notes that this reduction is only temporary and its “proactive publication level” will be restored to the level set out at the start of the policy once the relocation is completed.

This follows its previous announcement, on 27 June 2018, explaining that the Agency is no longer in a position to process access to documents requests issued from outside the EU.

The report also sheds light on the total number of documents published on the Clinical Data Publication (CDP) website, the amount of commercially confidential information (CCI) redacted, the reasons for rejecting redactions and the anonymisation techniques used by the Agency.

The report indicates that the EMA accepted 24% of CCI redactions proposed by pharmaceutical companies, with the overall result that only 0.01% of 1.3 million pages (3,000 documents) published contained CCI redactions. The most common reasons for rejecting redactions were insufficient justification and information already existing in the public domain. The key reasons for accepting redactions were the provision of detailed information on analytical assays or methods and justifications based on future development plans.

On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access to documents requests issued from outside the EU.

Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only “Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents.Continue Reading Update to the EMA’s Position on Access to Documents

While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months after the clinical trials portal and database (the EUPD) has been set up, independently audited, and notification of the successful audit published by the Commission. The operation of this database has been delayed a number of times, as the development of a system to cover so many aspects of the new Regulation is taking longer than expected.

Continue Reading Update on the EU Clinical Trials Portal and Database

The European Ombudsman, who investigates complaints of maladministration in the institutions and bodies of the European Union, recently handed down its decision in a case against the European Medicines Agency (EMA). The complaint concerned the EMA’s refusal to disclose the identity of parties who request access to documents held by the EMA. In the past, the EMA had stated that the “identity and/or the name of the organisation of the requestor will be used for the sole purpose of processing the request and will not be disclosed to third parties”. Instead, third parties, including the owner of the document requested, would only be told the request came from a “pharmaceutical company” or “law firm”. Last week, the Ombudsmen confirmed that the EMA has changed its policy in light of its recommendations.

Continue Reading EMA’s revised approach to disclosure of the parties who request access to documents