Global industry commits to new data openness
pharmafile | January 7, 2005 | News story | Sales and Marketing |
The global pharmaceutical industry has committed to making available all data relating to all marketed products, in a move designed to restore confidence in its practices and the safety of its products.
In June 2004 GlaxoSmithKline became the first ever company to promise complete online access to clinical trial data for marketed products, following allegations that it had concealed evidence of side-effects in children taking its antidepressant Seroxat (known as Paxil in the US).
Eli Lilly and Forest followed suit shortly afterwards, while the leading medical journals put forward their own proposals for a comprehensive online registry of clinical trial data.
Leading industry bodies such as America's PhRMA, Europe's EFPIA and the UK's ABPI have in the meantime been working on creating a consensus across the global industry, and have now reached a joint position on data disclosure.
The plans will see all industry-sponsored trials of products approved for marketing and which evaluate their safety and benefits published on openly accessible databases, regardless of their outcome.
One major complaint from the medical profession about current practice is that data on drugs that fail in clinical trials are rarely published, skewing the available data in favour of successful trials.
In the UK, the ABPI set up its own open access database in 2003, encouraging companies to voluntarily post their results, but uptake has been disappointing, with just a few companies adding their data to the website.
Dr Richard Barker, director general of the ABPI pointed out the association's lead in these efforts, and welcomed the industry's endorsement of the worldwide initiative.
The global industry has gone one step further than many had expected, and has also pledged to publish details of ongoing trials. The industry has been reluctant to disclose data on current trials until now, fearing competitors could use the information to their advantage, but it has now reached common agreement on how much can be disclosed.
Dr Barker said: "The industry recognises that there are important public health benefits associated with making clinical trial information more widely available to healthcare practitioners, patients and others. By publishing not just the results of trials that have taken place – whether positive or negative – but also those that are just starting, the industry has made a major step towards achieving greater transparency."
Dr Barker said it was now up to other sponsors of clinical trials, often academic institutions, to make a similar commitment. Like the industry, academics have rarely published results from failed research, but publication of these studies is seen as vital to provide as complete a picture as possible on medicines.
Apart from helping to create greater transparency, companies are likely to use the initiative as an opportunity to promote ongoing research to physicians and patients who want to participate in clinical trials.
Results will be published in a standard, non-promotional summary that will include a description of the trial design and methodology, primary and secondary outcome results as well as data on safety. If the results are published in one of the peer-reviewed journals, the database will include a link to the relevant article.
Results will normally be published within one year of the medicine being approved, or for post-marketing trials, within one year of them being completed.
The pledge comes as major investigations of industry practices in the US and the UK continue, with both inquiries hearing allegations of misconduct in the marketing of drugs and post-marketing pharmacovigilance.
The UK industry has not yet had the opportunity to defend itself against the investigation by the House of Commons Health Select Committee, but industry leaders will give evidence on Thursday 13 January.
Pharma insiders say they fear the UK inquiry could amount to little more than a witch-hunt of the industry, and are determined to resist far stricter regulation which the committee is likely to recommend.
