AUTH/3098/9/18 - Director v A Menarini

Clinical trial disclosure

  • Received
    12 September 2018
  • Case number
    AUTH/3098/9/18
  • 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 A Menarini 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.

The detailed response from A Menarini 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 of seven of A Menarini’s due trials had not been reported; the disclosure percentage was 69.6%.

The Panel noted from information provided by Menarini that six of the seven trials had no UK involvement.  The Panel considered that as there was no UK involvement, the matter did not come within the scope of the UK Code.  No breach of the Code was ruled in relation to these six trials.

The Panel noted that trial 2011-000805-27 had one investigation site in the UK.  The Panel noted that due to difficulties in screening and recruiting, only 4 of the planned 120 patients were randomized and the study was terminated early with the last patient out on 22 January 2014.  The Panel noted A Menarini’s submission that posting on EUCTR was deemed not applicable in this case since a minimum efficacy and safety dataset was missing.  Goldacre et al was silent on this point.  An abbreviated clinical study report was finalised and sent to the competent Regulatory Authority and the Menarini Company posted the trial on the company website explaining why it was prematurely terminated.  The Panel therefore ruled no breaches of the Code including no breach of Clause 2 in relation to this trial.