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Data transparency debate: Europe decides its future

Published on 24/03/14 at 07:50am
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Transparency became a major issue in 2013 as various new pressure groups sprung up with the shared aim of forcing pharma companies to release their trial information. 

But whilst these groups have had much public exposure, what have been less visible - but more important for the industry - are new plans for 2014 that will effectively force pharma firms in Europe to disclose more of their data than ever before. 

Leading the charge for greater transparency is the European Medicines Agency (EMA) which, since the arrival of new leader Guido Rasi, has put trial data at the top of its agenda.

The EU regulator has said that it will soon no longer view study data from pharma as ‘commercially confidential information’, meaning that all data could potentially be seen by parties outside of the EMA, something that has never happened before.

The plans were expected to come into force from 1 January this year but the European pharma industry, as represented by its lobby group EFPIA, has heavily criticised the EMA’s stance. EFPIA has warned that greater transparency may lead to private patient data being shared, and also worries that competing firms may use these data to outfox their rivals on new medicines.

Concerns are high too that data could be misinterpreted by those not trained to understand trial information. Given the growing furore, the EMA said it would delay its plans in order to go through the thousands of responses received - many of which were from pharma - whilst its ideas were out for consultation in 2013.

This has delayed the implementation of any new plans until March and at the time of press, the EMA board was discussing just what it will be doing next.

European Parliament

In addition to the EMA, there is also a new clinical trial regulation directive that has been approved by Public Health Committee MEPs in Brussels, but must now be debated and voted on by the European Parliament on the second and third of April, in order for it to become law. 

The regulation, if passed, will require anyone running a clinical trial to register it and publish a summary of results in a publicly accessible EU database. Currently, these types of data are stored on a database that can only be accessed by the EMA. 

Full clinical study reports (CSRs) are also expected to be published following marketing authorisation of a product, or if the marketing authorisation is withdrawn. This will be enforced by fines for any company that doesn’t adhere to the new transparency rules. 

Glenis Willmott, a UK MEP who is steering the legislation through the European Parliament, says: “For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. 

“It is vital that we know about negative outcomes - otherwise trials can be conducted repeatedly before it becomes public knowledge that some products are ineffective, or even dangerous.” The draft legislation, designed to encourage research whilst protecting patients’ rights, is to replace an existing directive with simpler, more uniform rules, she adds.  

The new text makes specific provision for low-intervention trials, clarifies the role of ethics committees in the authorisation process, and details how to obtain informed consent from patients. Further fines will also be imposed on sponsors who do not comply with these requirements. 

Willmott added that the transparency requirements are part of a wider piece of legislation which will streamline the regulations on clinical trials across Europe, facilitating cross-border co-operation to enable larger - and more reliable - trials, as well as those on products for rare diseases. 

Getting ahead of new rules

Whilst these new rules are being debated, many big pharma firms are looking to cash in on the PR of transparency by establishing their own path to greater data release. And in February, Novartis became the latest pharma company in a growing list to allow greater scrutiny of its clinical trial data. 

The Swiss firm said that researchers would now be able to request information on medicines that were newly-approved in the US and Europe through an internet portal called ‘ideaPoint’, a US site used by a number of pharma firms. Novartis’ plans do not, however, include access to older data. 

The transparency trend that seems to be spreading throughout the industry over the past 12 months sees Novartis join Leo Pharma, GlaxoSmithKline, ViiV Healthcare, Sanofi, Roche, Boehringer, Pfizer and Johnson & Johnson in releasing more data for public consumption. 

Of these firms, Boehringer, GSK, Roche, Sanofi and ViiV Healthcare all use the same ideaPoint. But each firm still has slightly different ideas about just how much data it should make available. J&J announced in January that it would work with Yale University’s Open Data Access Project (YODA) to release years of its drug findings to outside researchers. 

The firm has gone much further than most of its peers with its new plan by allowing YODA the right to send out its data to researchers, with the decision seemingly out of the US healthcare giant’s hands. This was ‘warmly welcomed’ by the UK-based transparency campaign group AllTrials - although J&J told Pharmafile it did not feel the need to sign the group’s register.

In the same month, Sanofi announced that it would expand access to information and data from its own trials - but with major restrictions. The French firm made it clear that this would only be effective from 1 January 2014, meaning data before this date will still be out of reach for external third parties. 

Since the start of 2014, Leo Pharma has been gradually releasing clinical trial data from studies dating back 24 years - it too, however, has told Pharmafile it will not be signing up to AllTrials. In fact, the only company to do so is the British firm GlaxoSmithKline, which was the first major drug company to laud the principles of transparency.

Since signing the campaign’s register a year ago, the London-based firm has added its anonymised patient-level data from the online request system it launched in May last year, to a new multi-sponsor request system (found at which includes studies from a number of other organisations.

GSK was also the first pharma company to allow outside researchers online access to detailed trial information, although it is yet to allow full, unfiltered access to all of its raw data: no company is yet willing to offer that.

Roche has been under the most pressure to release data after denying researchers from the Cochrane Collaboration access to its Tamiflu data for more than three years. It has since started working more closely with researchers to establish transparency, but has still not released full details on Tamiflu. 

And though the most vilified firm in terms of its image in relation to transparency, Roche is now working on a disclosure plan that is very similar to GSK’s. But in a warning to other companies, the public relations fallout for the Swiss major has done much to muddy its reputation. 

There are variations, but what remains similar across many of these firms - notably those using ideaPoint - is that access to their data is subject to assessment and approval by review panels, which are not always independent. The efficacy of ideaPoint also depends on study sponsors listing relevant trials on the site.

The rawest clinical trial data, formed of the original case report forms, still remain outside most discussions that predominantly focus on electronic, individual participant-level datasets. But if the raw data were not properly recorded, participant-level datasets will contain errors, which is why groups such as the Cochrane Collaboration want to see these types of data. 

Speaking to Pharmafile concerning those firms who are not releasing past data, Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials, said: “This isn’t the information we need. Restricting transparency to only new drugs - while still withholding information on the drugs we are already using - is a tiny dent.

“New drugs are a tiny fraction of all prescribing; it’s not even a start. We will be using the drugs we use today for decades. We need the full methods and results of all the trials on those drugs - anything less puts patients at risk.” 

What all this shows is that the criteria for granting access varies by the gatekeeper, but the general principle is to ensure that only qualified researchers pursuing legitimate research are granted access - and with that, access only to certain data, meaning there are still barriers. 

What this amounts to is that the average person is still barred from being able to simply look up the data of a drug they are using. This shows that, despite the rhetoric, pharma still sees clinical trial data as its property and not that of the public, or even of academia. 

It is this situation that could change dramatically with cohesive rules across the continent on just who owns the data, and who has the rights to them. If the EMA truly does follow the rule that these data are no longer commercially confidential, then the possibility of truly open data access will become a reality. 

ABPI response

The outgoing president of the ABPI Deepak Khanna, told Pharmafile that the decision to sign up for AllTrials ‘is for individual companies’ but argues that that there are reasons why a firm may not be able to sign up for AllTrials.

This includes if a firm merged within the last 10 years: “You couldn’t sign AllTrials in that scenario because you wouldn’t meet the criteria of the 20-year request.” Khanna goes on: “Protecting patient privacy, or the logistics of being able to get this done are quite frankly for many too much – and I question the relevance of having a 1,700-page CSR available. But you have to ask just what are we trying to accomplish.”

Khanna believes the ‘more important thing’  is the commitment of the industry to greater transparency. “When I look at what we have done internally with our own work to improve transparency with our members; giving them tool kits and the education about what needs to happen; and commissioning third party research to look at our public disclosure on industry sponsored trials.

“Quite frankly when we got the results, almost 90% of all trials have been made available. It shows you very good progress in the right direction. What I can say is that at the ABPI we are committed to the increase in transparency.”

A ‘UK problem’

When AllTrials was established in the UK by British groups in early 2013, it seemed as if this was a local issue to the country. But the changes being debated in the European Parliament and its drugs regulator show how quickly things have moved on. 

Just over a year ago, only a month after the establishment of AllTrials, UCB’s chief executive Roch Dovileux told Pharmafile that transparency was “a very UK topic […] I have difficulty even understanding the passion of the debate.”

In a bullish reply to Pharmafile questions on the subject of disclosure, he added: “A bigger topic in Europe is the whole internet quality of information: how do you give the right information to patients. That’s a real topic; we should really spend our energy on that.” 

But in an indication of just how much things have changed in the last 12 months, Dovileux had changed his tune significantly in late February this year during a conference held on his firm’s financial results. 

The outgoing UCB chief said to us: “I am pleased with the development that we have [made] - of course we want transparency. If you are patient-centric, you want your consumer to really understand what we are doing.” 

When asked what he would like to see in the EMA’s developing policy on clinical trial data disclosure, he added rather more reservedly: “I don’t know enough of the details to comment intelligently on that - I really don’t.” 

Culture change?

The new rules are yet to be established, but many firms are seeing the PR benefits of signing up to greater transparency - and getting in on the act early. But as has been shown, this is being done in many different ways. The question over past data is still a hot topic, and one that will need the hand of regulation to decide just what the public should expect from the industry.

But if the EU passes new regulations to open up data, will there really be the sort of sea change some in the industry, such as EFPIA, are worried about? In reality, few members of the public will race out to read thousands of pages of information about the medicines they are taking, and only trained mathematicians and scientists will be able to interpret these data. 

There will be some, most likely from the national media, who will seize these figures, try to mine them for stories and potentially get their interpretations wrong in the process. Undoubtedly, this would be very frustrating for pharma - but it should not be a reason to withhold data, as many have suggested to Pharmafile.

The bigger picture is that the public may not want to access the data themselves, but will feel assured that those not paid by the industry can see it, check it, and report any problems. It is simply another level of assurance, and one that can buy the industry some much needed PR kudos, something that it is currently lacking in the reputation department.

The change in culture around transparency will come from new rules, but will also need to come from an internal willingness on behalf of the industry. This is evidently developing in some firms, but the old paternal attitude towards ownership of data will eventually become redundant - and it is better for the industry to embrace, rather than resist, that change. 

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