Fight for clinical data ‘needs to go global’ : Nature News Blog

abernard102@gmail.com 2013-03-14

Summary:

"More needs to be done at the global level to ensure that researchers release all relevant data from clinical trials, experts told a House of Commons committee that is investigating openness in research. High on the agenda at today’s opening evidence session in an inquiry by Parliament’s Science and Technology Select Committee is whether pharmaceutical companies withhold data that might paint their drugs in a bad light, a subject that is attracting increasing attention in Europe and elsewhere in the world. 'We are eroding belief in medicines because people can’t trust the results that are published,' said Keith Bragman, president of the Faculty of Pharmaceutical Medicine. Fiona Godlee, editor in chief of the BMJ – which has published a number of articles attacking drug companies for lack openness on clinical trial data, notably regarding access to data on Roche’s Tamiflu – said, 'We recognise it’s a problem across the research enterprise.' Godlee is calling for legislation to mandate the publication of trial results and audits to ensure researchers and their funders comply. The UK Government is considering whether further measures should be added to new a new pan-European regulation governing clinical trials to force increased transparency. But the committee has been warned that any solution must be global. In its evidence to the committee, the charity Cancer Research UK said that 'isolated action at either the UK or EU level could further discourage clinical research from being located in Europe'. Godlee told the committee, 'We absolutely have to see this as an international problem and the solutions have to be international.' Mike Rawlins, speaking at the hearing for the Academy of Medical Sciences, said the Academy was planning to have discussions with the US Institute of Medicine about who should gate-keep access to clinical trial data that may be increasingly released for study outside of the original research team. 'These are trans-national issues,' he says. 'It’s no good one country trying to do its own thing without involving others.'”

Link:

http://blogs.nature.com/news/2013/03/fight-for-clinical-data-needs-to-go-global.html?utm_source=dlvr.it&utm_medium=twitter

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Tags:

oa.medicine oa.new oa.data oa.policies oa.comment oa.government oa.usa oa.legislation oa.consultations oa.europe oa.uk oa.biomedicine oa.clinical_trials oa.pharma

Date tagged:

03/14/2013, 14:41

Date published:

03/14/2013, 10:41