by ecancer reporter Janet Fricker
Last month the European Medicines Agency (EMA) held a work shop to debate the move towards proactive publication of clinical trial data once the marketing authorization process has ended. The workshop, held 22 November 2012 in London, elicited views from representatives of academia, industry, the media and patients.
In his opening address, Guido Rasi, the EMA’s Executive Director, underlined the Agency’s commitment to the initiative. “We are not here to decide if we will publish clinical-trial data, only how. We need to do this in order to rebuild trust and confidence in the whole system,” he said. “Patients make their bodies available to us, so we have responsibility towards them. In the long run, the scientific process will also benefit as new horizons open up. Science will only improve if data is shared.”
Peter Gøtzsvhe, Director of the Nordic Cochrane Centre, which is part of the Cochrane Collaboration, expressed concern that the current system allowed industry to be its own judge. “Patients take part in clinical trials to benefit science and future patients; they do not take part to benefit the shareholders of pharmaceutical companies,” he said. “Currently the only people who see all the data for new medicine are those inside the company – the company that stands to earn a lot of money from the product. The more eyes that look at the data, the better. The days of secrecy must end.”
Representing the media Virginia Barbour, Chief Editor of PLoS Medicine, said, “In terms of transparency, the short-term objective should be that all data used to support an application be made publicly available at the time of licensing. In the longer term, data from unsuccessful applications should also be made available. If we establish a vetting procedure for requests for data, then it should be a transparent one, where all requests are logged.”
The format in which the data was supplied, she added, would be crucial. “A 10-metre high pile of paper is useless; data should be available in an easily shared format,” she said.
Representing industry, Susan Forda, chair of the European Federation of Pharmaceutical Industries and Association’s (EFPIA) Scientific, Regulatory and Manufacturing Policy Committee, said industry would like to see data access reviewed on a case-by-case basis, with decision makers taking a range of factors into account, including the nature of the product, the data being presented, its place in the lifecycle and the method of release. “We also ask that the protection of intellectual property rights be fully considered,” she said.
EFPIA is not in favour of releasing information from withdrawn products or those that received a negative opinion. “This could damage the future interest of the product if it is resubmitted at a later date with additional data or submitted outside the EU,” she said. Furthermore if inappropriate data analyses were picked up by the media early in a product’s life cycle, she added, this could confuse doctors and prevent patients from receiving effective medicines.
Author Ben Goldacre, from the London School of Hygiene and Tropical Medicine, acknowledged that requests for data will come not just from independent academics but also from competitors. “That is reasonable and good,” he said. Furthermore, companies may be concerned about the theoretical risk to their products of bad analyses. “The solution is very simple – if all protocols and data are made public, anyone can question them,” he said.
Neil Weir, Senior Vice President of Discovery at UCB Pharma, suggested that a solution might be to appoint an independent assessor to decide what data should be accessible. “In terms of the greater good we must find a balance between fostering great science and an acceptable commercial environment,” he added. Significant investment had been made to gather the data, he stressed, and that if it was not owned by the funder this might lead to future problems.
François Houÿez, Health Policy officer at EURORDID, the European Rare Diseases Organization, said that there was always a risk that data could identify individual patients. To address this, he suggested that if data was to be shared with third parties, this should be clearly stated on the trial consent form, even if the third parties were not known at the time the consent was given.
At the close of the workshop Hans-Georg Eichler, Senior Medical Officer at the EMA, outlined the future plan of action. Advisory groups would be created in five key areas :protecting patient confidentiality, clinical trial data formats, rules of engagement, good analysis practice and legal aspects. “It was clear to us that we would have to cut one big problem into several smaller ones, each to be tackled by experts in that arena,” said Eichler. The agency, he added, would be able to adopt or politely refuse suggestions.
Detailing time lines, he said that the EMA plans to take final advice from each advisory group by 30 April 2013, to complete and issue for public consultation a draft policy on data transparency by 30 June 2013 and to publish a final policy on 30 November 2013, which would come into effect on 1 January 2014.
ecancermedicalscience believes that when negative studies illustrate important points they should be published. Our policy is that if a research question is important, original, and is answered with the right study design and sufficient power, it should be published, irrespective of the outcome.
Articles will be assessed based on the quality of the study design and significance of the topic/question, not on the success of the final results. In many cases, the effort and care put into a clinical trial makes it worthy of publication either to report significant results or avoid duplication of effort by future researchers.
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