AUTH/3069/9/18 - Director v Bayer

Clinical trial disclosure

  • Received
    12 September 2018
  • Case number
    AUTH/3069/9/18
  • Applicable Code year
    2016
  • Completed
    15 May 2019
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the Code of Practice Review

Case Summary

A study published online in the British Medical Journal (12 September 2018) was entitled ‘Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource’ (Goldacre et al 2018).

The study objectives included assessing compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) posted results to the registry within 12 months of completion (final compliance date 21 December 2016). The study objectives also included identifying features associated with non-compliance, ranking sponsors by compliance and building a tool for live ongoing audit of compliance. The published paper listed the trial sponsors with the highest proportion of trials reported and the trial sponsors with the highest proportion of trials unreported. The results were that of 7,274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results.

Goldacre et al stated that the European Commission (EC) Guideline required the results of all trials to be reported in structured form on to the register itself. It was possible that some trials that did not report results to EUCTR reported results elsewhere eg in a conference presentation, an academic journal article, as part of a meta-analysis after data were requested by systematic reviewers, or in the grey literature. Such publications did not meet the reporting requirements of the EC Guideline and were therefore outside the scope of the study.

Goldacre et al listed sponsors with more than 50 trials on the EUCTR and did not mention products or specific clinical trials. Goldacre et al gave details of disclosure of clinical trial results for each sponsor.

The Director decided that the Goldacre et al article was such that she had received information from which it appeared that Bayer might have breached the Code and decided in accordance with Paragraph 5.1 of the Constitution and Procedure to take the matter up as a complaint.

As Bayer had previously been ruled in breach of the 2008 Code in relation to its failure to disclose the results of studies on Xofigo within the permitted timeframe an alleged breach of undertaking was raised.

The detailed response from Bayer is given below.

General detailed comments from the Panel are given below.

The Panel noted the data in Goldacre et al in that the results for one of Bayer’s due trials had not been reported on EUCTR; the disclosure percentage was 98.6%.

The Panel noted Bayer’s submission that the trial in question (2012-004857-10) was authorised to proceed on 19 September 2013 but was cancelled before any patients were enrolled. The Panel noted Bayer’s submission that the EudraCT database did not provide functionality for sponsors to inform readers of EUCTR that recruitment for withdrawn trials never started, and so ‘completed’ was the only designation available to assign to this trial, which had led to the inappropriate inclusion of this trial in the BMJ article as a ‘due trial’.

The Panel noted Bayer’s submission that following receipt of this complaint the completion date had been deleted and the statement ‘Trial was withdrawn before start of recruitment, therefore no trial results available’ added in a data field below the study title in EudraCT.

The Panel noted that there were no results to publish and therefore ruled no breach of the Code including no breach of Clause 2.

Given the above there could be no breach regarding the undertaking given by Bayer in Case AUTH/2908/11/16 and therefore no breach of the Code was ruled in the present case including no breach of Clause 2.