AUTH/2667/11/13 - Member of the public v Amgen

Clinical trial disclosure (Nplate and Prolia)

  • Received
    18 November 2013
  • Case number
    AUTH/2667/11/13
  • Applicable Code year
    2012
  • Completed
    24 March 2014
  • Breach Clause(s)
    9.1 and 21.3
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    August 2014

Case Summary

​An anonymous contactable member of the public complained about the information published as 'Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe'. The study was published in Current Medical Research & Opinion (CMRO) on 11 November 2013. The study authors were Dr B Rawal, Research, Medical and Innovation Director at the ABPI and B R Deane, a freelance consultant in pharmaceutical marketing and communications. Publication support for the study was funded by the ABPI.

The study surveyed various publicly available information sources for clinical trial registration and disclosure of results searched from 27 December 2012 to 31 January 2013. It covered 53 new medicines (except vaccines and fixed dose combinations) approved for marketing by 34 companies by the European Medicines Agency (EMA) in 2009, 2010 and 2011. It included all completed company-sponsored clinical trials conducted in patients and recorded on a clinical trial registry and/or included in a European Public Assessment Report (EPAR). The CMRO publication did not include the specific data for each product. This was available via a website link and was referred to by the complainant. The study did not aim to assess the content of disclosure against any specific requirements.

The complainant stated that the study detailed a number of companies which had not disclosed their clinical trial results in line with the ABPI for licensed products. The complainant provided a link to relevant information which included the published study plus detailed information for each product that was assessed.

The summary output for each medicine set out the sources for all trials found, irrespective of sponsor and an analysis of publication disclosure in the form of a table which gave details for the studies for Nplate (romiplostim) and Prolia (denosumab).

The detailed response from Amgen is given below.

General detailed comments from the Panel are given below.

With regard to Nplate, the Panel noted that eight evaluable Nplate trials had not been disclosed within the timeframe. The disclosure percentage was 58%. One study completed before the end of January 2012 had not been disclosed. The disclosure percentage at 31 January 2013 of trials completed by the end of January 2012 was 95%. A footnote stated that the undisclosed trial reflected a terminated study with primary results analysis carried out in July 2012.

The Panel noted that Nplate was first approved and commercially available on 25 August 2008. The Panel noted that Amgen submitted data to show that five trials with UK involvement completed in May 2008, August 2008, July 2009, December 2011 and one was ongoing. The results of two trials which completed before Nplate was first approved and commercially available did not need to be disclosed under the Code as the product was available prior to the requirement in the 2008 Code. The matter was not covered by the 2006 Code as such and there could be no breach of it. Thus the Panel ruled no breach of the 2006 Code including Clause 2.

The two trials which completed after Nplate was first approved and commercially available completed in July 2009 and December 2011. These needed to be disclosed by July 2010 and December 2012 respectively. Amgen submitted that these were disclosed in October 2010 and December 2012 on clinicaltrial.gov. The Panel ruled no breach of the 2011 Code including Clause 2 in relation to the second trial. The Panel ruled a breach of the 2008 Code in relation to the first trial which completed in July 2009 and the results were not disclosed until October 2010. The delay in disclosure meant that high standards had not been maintained and a breach was ruled. The results had been disclosed and the Panel considered that there was no breach of Clause 2 and ruled accordingly.