The two largest pharmaceutical industry trade bodies have released joint principles for responsible clinical trial data sharing today. The principles include commitments that:
- Every pharmaceutical company will set up independent boards to review requests from researchers for access to clinical trial protocols, patient-level clinical trial data and study-level clinical trial data.
- Pharmaceutical companies will make publicly available synopses of clinical study reports for medicines that have been granted marketing authorisations, after the authorisation process has concluded.
The EFPIA and PhRMA commitments come into effect in January 2014. The report released today does not include measures to make old data – the evidence for medicines we use every day – available nor a commitment to registering all trials before they begin.
Industry plans on clinical trial transparency have been the focus of attention recently following the report in the Guardian on Monday of a leaked memo setting out EFPIA and PhRMA’s plan to mobilise patient groups to express concerns about release of clinical trial data, which some member companies have publicly distanced themselves from. Read EFPIA and PhRMA’s Principles for Responsible Clinical Trial Data Sharing (PDF).
Carl Heneghan, Centre for Evidence Based Medicine and co-founder of AllTrials said: “There are many details that need to be fleshed out to ensure this is little more than just window dressing.” Read Carl’s full comment here.
Ben Goldacre, doctor, author and co-founder of AllTrials said: “The industry commitments suggested here are weak and filled with loopholes. They fall way short of the concrete commitments the European Medicines Agency has already made about sharing trial information, and also fall short of recent commitments from GSK and Roche.” Read Ben’s full comment here.
Síle Lane, Sense about Science, co-founder of AllTrials campaign said: “While hundreds of patient groups and research bodies fight for an open, honest system of reporting clinical trials, others are fighting hard to cling on to secrecy. Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, for all medicines in current use. Discussions have started among the 350 organisations that have joined AllTrials, including members of EFPIA and PhRMA, on how to achieve this. GSK has announced that it will publish all the clinical study reports available since its formation as a company. That is genuine progress and an answer to patients who participated in those trials. Today’s proposals put EFPIA and PhRMA on the wrong side of history.”
BEUC, the European Consumers Organization said: “BEUC firmly believes that clinical trial data belong to each and every one of us and it should not be up to the industry to decide who should have access to them and in which form they should be made public. The data sharing commitment made today by EFPIA and PhRMA looks like an attempt to put the toothpaste back in the tube and they fall short in meeting consumers expectations and public health needs. The debate on transparency has already moved on and there is no way back. The pharma industry raised concerns about the risks of information being misinterpreted and cause health scare but so far we only have evidence of the public health risks of secrecy and non-disclosure. Many drug related scandals could have been prevented and many lives saved if trial data could have been subject to the scrutiny of independent researchers.
The statements made today should be read in connection with the industry attempt to mobilize patients groups for their commercial interests revealed by the Guardian two days ago and also in connection with the industry attempt to undermine the European Medicines Agency transparency policy in Court. BEUC decided to lend full support to EMA in the pending cases before the European Court of Justice and we will continue our campaign for transparency of clinical trials data for the benefit of consumers and medical progress.”
Trish Groves, Deputy Editor BMJ and co-founder of AllTrials said: “This shows we have won a battle, if not the war. So far only GSK and Roche have said they’ll share patient level data on request. Now we have these two pan-industry bodies stating: “Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request”. I think this is an important step along the way to full transparency, but there is still some way to go.”
Tom Jefferson, Epidemiologist, Cochrane Collaboration said: “The proposals fall far short of what experience has shown is acceptable. Any attempt at controlling information release on public goods like clinical trials is unacceptable. Fundamental tenets of research and scientific progress is reproducibility and open debate. You cannot have open debate if release is subject to constraints and different research groups are treated differently. We have seen this happening with the oseltamivir story.”
Peter Doshi, postdoctoral fellow, Johns Hopkins Medical School wrote an article in the BMJ saying: The recent joint statement of the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America of their principles for responsible sharing of clinical trial data has been misunderstood in two important ways, exaggerating the perceived progressiveness of the principles. Read the full BMJ article here.