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International Clinical Trials

Going Public?

‘Is pharma getting its act together over trial data?’– a simple question, but behind it lies a complex and divisive debate facing the industry.

The bone of contention is transparency of clinical trial data: should they be made publicly available so we know the real deal in terms of the efficacy and safety of trialled drugs; or would such a move cause alarm to patients and make them mistakenly think that the drugs they use are unsafe and have not been properly tested?

It’s a row that looks set to dominate this year and beyond – and this was made abundantly clear at a recent PharmaTimes debate which gave those on both sides the chance to air their views in front of a packed audience of pharma industry executives and healthcare practitioners.

Held in late February in London, the event saw doctor, author and academic Ben Goldacre go head-to-head with Stephen Whitehead, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI), in what proved a lively but pointed discussion.

Broken Evidence Base

Dr Goldacre – who believes that unpicking bad science and inaccurate scientifi c claims is the best way to explain good science – argued that the industry is not getting its act together over transparency. While recognising that many ethical people work in pharma today, he warned that there is “a broken and incomplete evidence base for medicine” and called for collaboration across the industry to tackle the problems.

“Dissemination of trial results is the big issue,” he said. According to robust sources, only 50 per cent of trial data, both from academic and industry-led trials, is made public. In addition, he claimed that many trials are not properly registered or not registered at all. He also raised concerns over the low level of compliance with trial regulations, and said the lack of fi nes by the Food and Drug Administration (FDA) – and low penalties when fines are imposed – does little to help the situation.

Campaign Calls

Dr Goldacre’s view is that “the pharma industry advocates the health benefits of products through aggressive marketing, while under-reporting trial results and potentially concealing data about adverse effects – all in the name of profits”. Such an approach might also hide poor trial design, he said. “The industry has its head in the sand and is not engaging in debate enough – it must show leadership on the issue,” he stressed.

Prompted by these concerns, Dr Goldacre has mounted a campaign for greater transparency and registration of trials. The AllTrials initiative, launched in January in conjunction with the BMJ, the James Lind Initiative and the Centre for Evidence-Based Medicine, calls for measures to ensure that “all clinical trials past and present” are registered and “the full methods and the results” reported.

In particular, it has urged the publication of study reports from all clinical trials carried out since the 1990s on treatments currently in use internationally, so that doctors and patients know the full picture in terms of efficacy and safety. The initiative also says the proposed new European Regulation for clinical trials does not go far enough in the registration and reporting of trials.

The campaign is gaining momentum. It has received backing from politicians, the Medical Royal Colleges and patient groups, while GlaxoSmithKline and the UK’s National Institute of Health and Clinical Excellence have now signed up.

Industry Defence

In response to this, Stephen Whitehead, Chief Executive of the ABPI, which represents innovative research-based biopharma companies, was keen to “set the record straight”. While acknowledging the need for greater transparency in trial data, he mounted a strong defence of the industry’s approach to date and offered a reminder of the widespread good practice across the pharma world.

Taking the view that pharma is getting its act together, Mr Whitehead spoke out against the methods used by the AllTrials initiative to drive their cause. “The campaign is an unfair attack on the credibility of the industry, and is alarming to patients who think they are being given drugs that have not been properly tested – this is not true.”

He disputed Dr Goldacre’s fi gure that only 50 per cent of trial data is published and claimed that it was closer to 78 per cent, according to sources from the FDA and European Union. He also emphasised that “we have a very strong regulatory process for reporting adverse events”.

However, he did find some common ground with Dr Goldacre, agreeing that greater data transparency “is the friend of knowledge” and should be welcomed by the industry. “We all share an interest in patient wellbeing,” he added.

ABPI Position

Mr Whitehead agreed that clinical trials summary reports should be made available for new and existing medicines, but said that methods to do this are still being finalised. He also clarified that the ABPI is against a wholesale “data dump” of trial study reports for current treatments, as advocated by AllTrials. Instead, it has opted to wait until the European Medicines Agency makes recommendations on the mechanics of releasing trial data, due later this year.

The ABPI position is that companies would rather spend time developing new medicines than going through millions of pages of data from historic trials. It also says that the potential publication of full trial results raises concerns over data privacy relating to the preservation of patient anonymity and the protection of commercially confidential information.

Following the debate, the ABPI announced more rigorous measures to boost compliance with the data transparency elements in its code of practice. The code requires companies to register a trial within 21 days of the fi rst patient being admitted and post the results within one year of marketing authorisation. However, with this process not fully monitored to date, the ABPI says that an independent provider will now be appointed to police it, and a new best practice toolkit will be available later this year.

Mr Whitehead also said we should not forget the massive positive contribution made by the industry. “Yes, there are examples of bad practice in pharma, but this is not the norm,” he said, concluding that the work of ‘good pharma’ – including the development of vaccines, better treatments for dementia, meningitis and cancers, and new drug approvals – shows that medicine is not broken in the UK or globally.

Wake-Up Call

Wherever you stand on the issue, it is clear that the debate over trial data transparency is here to stay. Dr Goldacre’s campaign has kick-started a discussion that may yet prove a wake-up call for pharma, perhaps helping to increase trust in medicines and ultimately improve life-saving treatments and patient compliance. And yet the industry is sensibly cautious about rushing towards a future without fi rst considering the impact of change. As one audience member at the debate commented: “The industry is slowly getting its act together, so let’s shout about the good stuff, while rooting out the bad.”

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