The Association of the British Pharmaceutical Industry (ABPI) released a statement about the AllTrials campaign which did not address what AllTrials is calling for. We wrote to them to point this out and they replied again, still not addressing what we are calling for so we asked them to answer some direct questions.
18th January 2013 ABPI statement
23rd January 2013 We respond to ABPI statement
“AllTrials calls for the publication of clinical study reports from all clinical trials since the 1990s and for all trials to be registered. It is not a campaign for releasing individual patient data. The only mention made of publishing clinical trials results in the ABPI response is with reference to the ABPI Code of Conduct, which is only for new trials rather than earlier trials relating to treatments currently in use. The ABPI’s statement appears to contradict the Code by saying that there are commercial reasons not to follow it.
The development of new treatments, patient confidence and regulatory oversight can only benefit from having full information about the trials that have been done before and what they have found. It is important that industry engages with this issue. We are not campaigning on access to individual patient data; that is a separate issue. Please can you respond to our call for access to clinical study reports and summary trial results on all trials for currently used
24th January 2013 ABPI replies to us
“Like you, we do believe that greater transparency of clinical trial results, and appropriate access to trial data, past and present, is in the best interests of patients and medicine. We also agree that all trials should be registered, which is a requirement of the ABPI Code of Practice.
Regarding the call from the AllTrials campaign for the publication of clinical study reports from all clinical trials since the 1990s, we support greater access to trial data but as you are aware, this is a complex issue since research and development is an international endeavour. As such, the UK cannot act in isolation. This is why we support the European Medicines Agency’s initiative to disclose trial information and the creation of working groups to examine the many complexities in making disclosure feasible. We believe it is necessary to wait for the outcomes of the working groups in order to establish systems and processes to disclose CSRs in line with the EMA final recommendations.
As we acknowledge in our statement, the debate around clinical trial transparency is important but it is also essential that patients have confidence in the medicines their doctors prescribe and understand that the regulatory authorities have access to all the relevant data as part of the approval process for new medicines, regardless of how much data is ‘published’.
The ABPI welcomes your contributions to this important debate and we do believe t
here is much common ground. Please do feel free to contact me if you would like to discuss this in person.”
29th January 2013 We ask ABPI some direct questions
“Thank you for your reply. Your comments are still on the subject of individual patient data. As our last response to you emphasised, All Trials is calling for publication of clinical study reports for all treatments in use internationally. Your position on this is as unclear as it was before you issued two replies.
There is no need to wait until 2014 for an EMA consultation on individual patient data to end before answering our questions on clinical study reports. Attempts to address transparency have suffered from these kinds of irrelevant delays since first being raised in the 1980s, which suggests that industry does have objections to the publication of clinical study reports for treatments in current use. If so, these should be set out clearly and specifically.
Perhaps a better way to clarify it would be for ABPI to answer directly the following questions:
Do you agree that clinical study reports etc should be provided for all treatments in current use (and that where these are not available an account given of this by the Principal Investigator)?
Do you agree that this information should be publicly available?
Will you amend your 2012 guidelines to this effect?
Will you support an amendment to the EU Clinical Trials Regulation to this effect?
What, if any, are your commercial objections to publication of clinical study reports?
What kind of situations do you think would justify withholding clinical study reports?”