Thursday, October 24, 2013

Drug industry can profit from clinical-trial data openness, say leading regulators

The drug industry’s opposition to greater access to clinical trial data is misplaced, four senior figures in the European Medicines Agency (EMA) said today.

The agency is preparing to vastly expand the amount of information it makes available to researchers, and is close to finalizing a policy on making public data submitted to it by drug companies applying for licences for new medicines. Some elements of the pharmaceutical industry have fought back, complaining that this will release confidential data crucial to its interests and harm investment in the development of new drugs (see ‘Secrets of trial data revealed‘).

But writing today in the New England Journal of Medicine, an EMA team says that putting clinical trial data in the public domain will make it more cost-effective to develop new medicines — for example by making sure one company does not run down a blind alley already mapped by another and by providing more information that companies can use to prove the superiority of their treatments over rivals’ drugs.

“It is ironic that the organisations that most resist wider access to data are the ones that stand to benefit so much from greater transparency,” write the EMA experts, who include senior medical officer Hans-Georg Eichler and executive director Guido Rasi. Despite their roles in EMA, the authors wrote in a personal capacity.

They add: “Contrary to industry fears, we argue that access to full — though appropriate deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.”

In another article published alongside the piece by Eichler and his colleagues, Michelle Mello, a health-policy researcher at the Harvard School of Public Health in Boston, Massachusetts, and her colleagues set out a set of principles by which data can be safely and usefully shared, down to the level of information from individual patients.

“As in other areas of health care, the push for greater transparency in the area of clinical trial data appears inexorable,” they write. “The question is not whether, but how, these data should be broadly shared.”

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