NICE has confirmed that it has signed the AllTrials campaign, which aims to make all clinical trial data available for public scrutiny.
NICE has confirmed that it has signed the AllTrials campaign, which aims to make all clinical trial data available for public scrutiny.
Rumours were abound last night on the social media channel Twitter that the UK drug pricing watchdog had signed up to the scheme, which is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports to help drive further scientific understanding.
A spokesman for NICE confirmed to PharmaTimes UK news that NICE has now signed up to AllTrials. Sir Michael Rawlins, chair of NICE, told PharmaTimes: “We strongly believe that all clinical trial data should be made available so that that those with responsibility for developing clinical guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.”
Firms for many years have been accused of not releasing full clinical trial data, and are believed to be ‘burying’ negative trials as these could impact the sales potential of their medicines.
Today’s announcement is a big deal given that NICE is a government-associated body and the primary health technology assessor for pharma drugs in England. It is also recognised globally as the best HTA body and this reputation is helped by its offshoot NICE International, which is helping countries around the world set up or refine their HTA processes.
By backing the campaign, AllTrials now has in NICE a highly reputable organisation at the forefront of assessing pharma data saying that the industry must do more to open up its clinical trial data.
Although NICE will not make a decision on a drug’s efficacy – this is up to the European Medicines Agency – it will sift through a drug’s clinical data during its appraisal in order to see whether the efficacy it can deliver is akin to the price a firm is asking. If a firm is withholding data, this can affect NICE’s ability to accurately assess a drug’s QALY, and could mean the NHS is paying too much for some medicines.
The AllTrials campaign is being supported by Bad Pharma author Dr Ben Goldacre and BMJ editor Dr Fiona Godlee. On hearing the new Dr Goldacre tweeted: “Hurrah! About time too!”.
Earlier this month the campaign received a major boost when UK-based firm GlaxoSmithKline became the first pharma company to sign its register.
GSK has so far been the only firm to take this step – the ABPI has said it will not sign up to full public disclosure, citing concerns about patients’ privacy.
AllTrials wants to see the publication of study reports from all clinical trials conducted since the 1990s on treatments currently in use internationally, as well as registration of all clinical trials.
GSK backs AllTrials campaign
GlaxoSmithKline has become the first big pharma firm to support the AllTrials campaign that aims to increase clinical trial transparency.
The campaign, which is being supported by Bad Pharma author Dr Ben Goldacre and BMJ editor Dr Fiona Godlee, is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports to help drive further scientific understanding.
Goldacre immediately took to Twitter to express his delight that GSK has signed up to the campaign, saying the firm’s backing was: “Amazing.Fantastic.Historic[…]This is the beginning of the end for a dark era in medical history.”
The industry has been resistant to publishing all of its data for the public to see, and the UK lobby group the ABPI has stopped short of signing up fully toAllTrials. This seemingly looks as if GSK is breaking rank, but the ABPI said: “The decision to sign up to the Alltrials campaign is one for individual companies to make. The ABPI has long been an advocate of greater transparency in clinical trial data balanced with the need to ensure that disclosure policies protect patients’ personal data, companies’ intellectual property rights and confidential commercial information.”
Increasing transparency
GSK already publicly discloses a significant amount of information about its clinical trials – but not all of them – and is the first big pharma firm to get behind the AllTrials campaign.
Its backing comes despite the firm being found withholding information about the safety of its diabetes drug Avandia, drawing criticism from both the BBC Panorama programme and the BMJ. The firm is accused of trying to bury negative data from Avandia’s RECORD study, which began in 2001 and was published in 2009.
The firm currently registers and posts summary information about each trial it begins and shares the results of all its clinical trials – whether positive or negative – on a website accessible to all.
This website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. The company has also previously committed to seek publication of the results of all of its clinical trials that evaluate its medicines to peer-reviewed scientific journals.
Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register.
From now on, GSK says it will publish CSRs for all of its medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will however be removed says GSK, in order to ensure patient confidentiality is maintained.
Dedicated team
In addition, the company also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information.
Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.
Patrick Vallance, president of pharmaceuticals R&D at GlaxoSmithKline, said: “We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research. All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”.Separately, in October 2012, and going further than the call made by the AllTrials campaign, GSK announced it would develop a system where researchers will be able request access to detailed anonymised patient level data that sit behind the results of clinical trials to enable additional scientific inquiry and analyses to help further scientificknowledge.
ABPI holds to conditional release of clinical-trial data
While clinical study reports for all medicines currently in use should “in principle” be available to the public, the company responsible must be involved in identifying which elements of those data “should not be disclosed due to data privacy concerns or to protect commercially confidential information”, insists the Association of the British Pharmaceutical Industry (ABPI).
The ABPI was clarifying its position in the ongoing debate over clinical-trial data transparency under increasing pressure from AllTrials, the transparency campaign backed by epidemiologist and Bad Pharma author Dr Ben Goldacre, the BMJ, the James Lind Initiative, the Centre for Evidence-Based Medicine and Sense About Science.
AllTrials, which sent the ABPI some specific questions about its stance on the release of clinical-trial data after claiming the association had been evasive in its previous responses to the campaign’s queries, wants to see the publication of study reports from all clinical trials conducted since the 1990s on treatments currently in use internationally, as well as registration of all clinical trials.
The ABPI says it believes more transparency around clinical-trial results, and “appropriate access to trial data, past and present, are in the best interests of patients and medicine. It also suggests there is “much common ground” with AllTrials on these issues.
Nonetheless, the association continues to resist a wholesale ‘data dump’ and to counsel prudence until the European Medicines Agency’s (EMA) working groups report on the mechanics of releasing trial data later this year.
Prioritise studies
Asked by AllTrials whether it agrees clinical study reports for all treatments currently in use should be publicly available, the ABPI says industry would “urge civil society to prioritise what studies are most important to release”.
It is “simply impossible for regulators and companies to release all study reports at once”, the association continues.
“Companies would rather spend time developing new medicines than going through millions of pages of historic data. Also, there must be a process of co-ordinating this process among the regulatory agencies – the same study reports have been submitted to agencies all around the world.”
Data exclusivity
The association generally favours redaction of patient-identifiable data or commercially sensitive information rather than withholding study reports.
All the same, it does emphasise the importance of data- and market exclusivity as a lever for research and development investment.
When a company does not hold a patent on a product, “it relies on ‘regulatory data protection’ to get the necessary market exclusivity to recoup the investment made”, the ABPI comments.
“This period is 10 years in the EU. If the entire file with all studies is released other companies can get approvals around the world.”
Commercial plans
One complication, the association says, is that, until now, clinical study reports have been “written for a regulatory audience and assuming confidentiality, they may describe commercial plans of the company”.
For example, a report may set out the development strategy for future studies on new indications for a drug “to put the particular study in context”, the ABPI explains.
In some cases, it adds, companies “may consider that a particular study design is a trade secret that competitors can learn from. Furthermore, study reports often include appendices with detailed information on analytical methods (chemical and physical) and on the manufacturing of the clinical trials material”.
The ABPI’s “overarching belief is that greater transparency of clinical trial information is in the best interests of patients,” it states. “We are supportive of the EMA’s efforts to identify the best way to do this and are engaged in the discussion on how it can be done.”
