Pharma Industry Groups Outline Principles for Transparency

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Advocates of clinical trials data sharing blast a new proposal of principles from American and European pharmaceutical groups as "window dressing" that fall short of actual concrete commitments.

This article published with permission from The Burrill Report.

The leading pharmaceutical industry trade groups in the United States and Europe have issued a set of principles for clinical trial data sharing in an effort to craft an alternative to European regulator’s efforts to make the information more freely available.

Industry officials say the principles reflect pharmaceutical companies’ commitment to share trial data in a way that protects patient privacy while benefiting patients and fostering scientific discoveries without second-guessing regulators or compromising commercial confidential information.

The principles proposed by the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations provide a “responsible alternative” to proposed policies by the European Medicines Agency.

The trade groups believe that proactive, indiscriminate disclosures of companies’ non-public data submitted in clinical and preclinical dossiers, and of patient level datasets risks “damaging public health and patient welfare,” said John Castellani, president and CEO of PhRMA, during a conference call with reporters. “Government disclosures of companies’ unprocessed and non-contextualized raw data and technical analysis, we believe, will provide little benefit to practicing health care professionals and patients and could potentially jeopardize public health in the long run.”

AllTrials, a campaign involving medical journals, research institutions, patient groups and industry that advocates for the registration of all clinical trials and the availability of all data reported, blasted the principles as “weak and filled with loopholes,” saying that they fall “far short of the concrete commitments the European Medicines Agency has made about sharing trial information.”

“It’s pure window dressing. We have a very reasonable EMA policy on release, but these guys want to retain control of the data,” said Tom Jefferson, an epidemiologist with the Cochrane Collaboration who was involved in a high-profile four-year fight to obtain Tamiflu clinical trial data.

“We stuck it out for four years and in the end are beginning to get what we wanted without committees, or stings of any kind,” he said. “Reproducibility and open science is what we need in a public good like a clinical trial.”

The release of the principles comes as the industry seeks to rein in policy efforts in both Europe and the United States, to present a united front over the extent to which patient-level clinical trial data should be made available to the public, and to influence who will serve as the gatekeeper to that information.

The intensity surrounding the issue is building with a legal battle in Europe that could derail an EMA transparency policy from moving forward at the start of 2014. It also comes as the Institute of Medicine prepares a consensus report on the issues surrounding data transparency and the U.S. Food and Drug Administration seeks public input on a policy of its own.

Under the principles put forward by the two trade groups, companies would voluntarily provide data. Each company would establish a scientific review board of scientists and health care professionals not employed by the company and determine the qualifications of the requestor of data and whether the research purpose of the request is legitimate.

Data would be anonymous to protect individual identity, but it would also not be released if informed consent agreements prohibit the transfer of the data to third parties. The full principles can be found on the PhRMA website.

PhRMA said implementation of the commitments in the principles will begin on Jan. 1, 2014. Companies will start reviewing requests for data from researchers at that point, but Castellani said companies will need to take into account patients’ informed consent. He said it will not be possible to share data from many earlier trials because patients participating in them did not consent to such release.

However, GlaxoSmithKline, a signatory to the AllTrials campaign and a member of both PhRMA and EFPIA, has already said it will make available to researchers clinical studies reports dating back to 2000 when the company was formed through a merger of Glaxo Wellcome and SmithKline Beecham.