AUTH/3078/9/18 - Director v Amgen

  • Received
    12 September 2018
  • Case number
    AUTH/3078/9/18
  • 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 Amgen 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 Amgen had previously been ruled in breach of Clauses 9.1 and 21.3 of the 2008 Code in relation to its failure to disclose the results of studies on Nplate within the permitted timeframe an alleged breach of undertaking was raised.

The detailed response from Amgen 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 two of Amgen’s due trials had not been reported in EUCTR; the disclosure percentage was 96.1%. The Panel noted that Amgen identified three studies mentioned as ‘not reported’ in the live data link. The Panel decided to rule on the three trials identified by Amgen.

The Panel noted Amgen’s submission that trial ID: 2017-000675-90 was terminated before it started and no data were collected. The EU Clinical trials register stated that the trial was ‘prematurely ended’ on 29 May 2017. The Panel further noted Amgen’s submission that there were no UK centres, investigators or patients involved.

The Panel noted Amgen’s submission that no patients were enrolled in Trial ID: 2007-000570-22 which involved the investigational product AMG 745, global development of which was stopped on 9 January 2008. The Panel noted Amgen’s further submission that there were no UK centres, investigators or patients involved.

The Panel considered that as there was no UK involvement, the matter including the alleged breach of undertaking in relation to trials 2017-000675-90 and 2007-000570-22 did not come within the scope of the UK Code. No breach of the Code was ruled.

The Panel noted Amgen’s submission that trial ID: 2014-003701-15 involved the investigational product brodalumab, the development of which was stopped by Amgen in 2015. The Panel noted Amgen’s submission that although UK centres were to be involved, the trial was terminated before any UK centres were initiated and prior to recruitment; no data were collected. The EU Clinical trials register stated that the trial was ‘prematurely ended’ on 28 May 2015. There were no results to report. The Panel therefore ruled no breaches of the Code including no breach of Clause 2.

Given this ruling there could be no breach regarding the undertaking given by Amgen in Case AUTH/2667/11/13 and no breaches of the Code including no breach of Clause 2 was ruled.