GSK announces AllTrials support
pharmafile | February 6, 2013 | News story | Research and Development, Sales and Marketing | ABPI, Bad pharma, GSK, Goldacre
GlaxoSmithKline has this morning found itself in the unusual position of being showered with praise by one of its fiercest critics.
GSK has announced its support for the AllTrials campaign for clinical data transparency – the first pharma company to do so.
Ben Goldacre, a leading light in the campaign and whose book Bad Pharma was highly critical of what he sees as manufacturers’ undue secrecy, said it was a ‘historic moment’.
AllTrials is calling for clinical trials to be registered and the disclosure of their results plus clinical study reports (CSRs) to help improve transparency and aid research. GSK already registers and posts summary information about each trial it begins, and shares the results of all trials on an open-access website.
At present it has almost 5,000 clinical trial result summaries online but has now committed to make CSRs publicly available through its register too. These are formal reports which detail the design, methods and results of trials and form the basis of submissions to regulators.
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” to allow researchers to look at them.
Patient data in the CSRs and their appendices will be removed to ensure confidentiality, GSK insists. The manufacturer says it also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK in 2000.
“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,” the company said in a statement.
CSRs for GSK’s most commonly-prescribed medicines will have priority.
“We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment,” said Patrick Vallance, GSK’s president, pharmaceuticals R&D.
All companies, academics and researchers “have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit”, he added.
Among one of many celebratory tweets, Goldacre said the news was: “Amazing. Fantastic. Historic.”
He also revealed that he had met with GSK chief executive Sir Andrew Witty last Friday to discuss his concerns, saying: “It was clear that they’ve spent a lot of time thinking about these issues.”
“I couldn’t be any happier,” Goldacre said. “This is huge, and internationally huge. Thanking GSK for its decision, he added: “This is the beginning of the end for a dark era in medical history.”
He went on: “They have also made sensible noises about the practicalities, which shows that they have thought about the implications, and they also discuss prioritising which CSRs to work on first.
“Because they have discussed these technical details – while I will always wait for the proof in the pudding – I do not believe this is mere lip service,” Goldacre concluded.
This is a ringing endorsement of GSK and the company’s decision could yet be part of an unstoppable tide for pharma.
The European Medicines Agency is already working on exactly how it will release clinical trial data from next year. Reports from its working parties are expected in April.
However, European pharma trade body EFPIA has already said it is against what it calls ‘indiscriminate’ transparency.
But Goldacre tweeted that GSK’s decision was a “Wake up call for investors. GSK will share. So, what are the others afraid of? What are they hiding?”
He added that an unnamed ‘policy wonk’ had sent him a message saying: “Where is your God now ABPI,” a reference in part to the ABPI’s insistence that Bad Pharma’s examples of poor practice were historical.
In a statement on GSK’s decision the ABPI insisted: “The decision to sign up to the Alltrials campaign is one for individual companies to make.”
It added: “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.”
ABPI also points out that Alltrials is “one of a number of initiatives addressing the transparency issue”, citing others including the EMA working groups, the House of Commons Science and Technology Committee Inquiry and changes to the ABPI Code.
Adam Hill
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
GSK shares results from phase 3 trial for gonorrhoea treatment
GSK has announced positive results from its phase 3 EAGLE-1 trial for gepotidacin, a potential …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
