Pharma should not have to release raw data sets directly for public scrutiny.
The former Director General of the ABPI has toldPharmaTimes UK news that pharma should not have to release raw data sets directly for public scrutiny.
The AllTrials campaign is gaining momentum with bigger names – and now even pharma firms – signing its register to publish all clinical trial data.
The campaign, set up by ‘Sense about Science’, the British Medical Journaland Bad Pharma author Dr Ben Goldacre, is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports to help drive further scientific understanding.It specifically 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.
More than 80 patients groups have signed the register, with GlaxoSmithKline and NICE – as exclusively revealed by PharmaTimes this week – quickly following suit, all of which have led to Dr Goldacre’s delight on the social media platform Twitter.
But the campaign has not stated that it wants to see ‘raw data sets’ – i.e., clinical data in its original, pre-published form with no filtering from pharma or anyone else. GSK has signed up to release clinical study reports – but will not be sharing its raw data sets. No other pharma firm has yet signed the register (at time of publication) and the ABPI has voiced its concerns that this could endanger patient privacy.
Published results vs. raw data
Professor Trevor Jones, formerly Director General of the ABPI, told PharmaTimesUK news: “GSK is to be applauded for confirming that they will publish peer reviewed Clinical Study Reports when the product is approved or discontinued.” But Prof Jones says that this is a “long way” from publishing raw data.
He adds that Dr Goldacre claims the GSK’s signing as a success for his campaign, something that has brought him good publicity. “But will he continue to pursue his call for the publication of raw data?” he asks.
Prof Jones says that GSK’s approach is the right one, adding that he is “absolutely opposed” to complete open access to raw data by anyone from any source for any reason, and then using whatever analytical methodology they wish (spurious, scientifically valid or not) to re-analyse data that rightly have been the subject of rigid methodological review by competent authorities.
“I have to say that the industry, necessarily and properly, is already subjected to that degree of rigour and scrutiny through the rules for its submission of data to regulatory agencies such as FDA and the EMA. There is, of course, always a case for further independent review provided the reasons for such reviews are valid and that such analyses are carried out by competent authoritative bodies against agreed protocols and methodology and ,importantly, that the results of their analyses are properly peer reviewed before publication.”
He says that to do otherwise calls into question the integrity and competence of the existing legal and societal processes that have been established to evaluate and ensure the safety and efficacy of medicines.
Jones says that the situation is analogous to a customer using an aeroplane: “I do not expect that each and every passenger or their family or colleagues should need to have the opportunity to see all the logs of every aeroplane in the fleet, the logs and records of every airport maintenance, re-fuelling staff, de-icing procedure, the medical records of the ground staff, pilots and cabin crew, chefs, etc., to establish my view as to whether it is adequately safe for me to travel.
“We must rely on the regulators and the process of regulation and if that is ever found to be deficient then clearly it needs to be revised by proper procedures. If we undermine that process then, surely we will be subject to increasing misinformation from often incompetent – or even mendacious – sources with attendant media scares, and especially in the case of our medicines, a loss of confidence by patients in their medicines – a situation that can be deleterious to their health.”
He adds: “Whatever system of raw data review is adopted, all this will cost more money and resource from both the industry and the regulators. Money and effort that will thus be diverted from finding new and better medicines – .i.e., a further blow to productivity.