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AUTH/2898/11/16 and AUTH/2901/11/16 - Director v Roche

Case number:AUTH/2898/11/16 and AUTH/2901/11/16
Case ref:Director v Roche
Description:Clinical trial disclosure (Kadcyla and Perjeta)
No breach:No breach Clause 2
Breach:Breach Clauses 13.1 and 9.1
Appeal:No appeal
Status:Breach ruled, case report pending - previously displayed in error as no breach outwith the scope of the Code
Review:Published in the May 2017 Review
Received:06/12/2016
Completed:13/03/2017
Case Summary:

​A study published online in Current Medical Research & Opinion (CMRO) on 25 November 2016 was entitled ‘Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013’. The study authors were B R Deane, a freelance consultant in pharmaceutical marketing and research and Dr J Sivarajah, Head of Medical Affairs, ABPI. 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 between 1 May and 31 July 2015. It covered 34 new medicines (except vaccines) from 24 companies that were approved by the European Medicines Agency (EMA) in 2013. 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 in the supplemental information via a website link. Neither the study nor the supplemental information identified specific clinical trials. The study did not assess the content of disclosure against any specific requirements. 

The Director decided that the study was such that she had received information from which it appeared that Roche 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 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 Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab). 

The detailed response from Roche is given below. 

​General detailed comments from the Panel are given below. 

With regard to Kadcyla, the Panel noted the CMRO publication in that one evaluable trial had not been disclosed within the timeframe. The disclosure percentage at 12 months measured from the later of the first date of regulatory approval or trial completion date was 91%. 

The disclosure percentage at 31 July 2015 was 91%. Kadcyla was first approved and commercially available in February 2013.

With regard to Perjeta, the Panel noted the CMRO publication in that one evaluable trial had not been disclosed within the timeframe. The disclosure percentage at 12 months was 95%. The disclosure percentage at 31 July 2015 was 100%. 

Perjeta was first approved and commercially available in June 2012. 

The Panel noted Roche’s submission that the alleged undisclosed trial in each case related to one Phase Ib/IIa study which included both Kadcyla and Perjeta. The trial was conducted in multiple sites by Roche global and included one UK trial site and thus fell within the scope of the ABPI Code with regard to disclosure as acknowledged by Roche. 

The Panel considered that the Second 2012 Code and the Joint Position 2009 applied based on the first commercialisation of Kadcyla.

The trial completed on 24 October 2013 which was after the date of commercialisation for both Kadcyla and Perjeta. The Panel noted that on the information before it the trial results should have been posted by 24 October 2014. The Panel noted Roche’s submission that the trial at issue was registered on ClinicalTrials.gov on 6 July 2009 however due to an incorrect Phase I categorisation (rather than Phase I/II) within Roche, results were not posted to ClinicalTrials.gov. The trial had now been reclassified within Roche. 

The Panel noted that data from the trial was published at the San Antonio Breast Cancer Symposium, in December 2012 (interim analysis) and December 2013, however the complete results had not been posted on a publicly accessible, internet based, clinical trials database within the required timeframe as acknowledged by Roche. The Panel thus ruled a breach of the Code. The delay in disclosure meant that high standards had not been maintained and a breach of the Code was ruled. 

As the data had now been disclosed the Panel considered that there was no breach of Clause 2 and ruled accordingly.​