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Bayer, Boehringer Ingelheim Open Clinical Trial Data

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14 May 2014. Two more pharmaceutical companies, Bayer HealthCare and Boehringer Ingelheim, are making detailed data from clinical trials available to the larger scientific community. The two companies join several other pharmaceutical companies taking similar actions over the past several months.

Bayer HealthCare in Leverkusen, Germany is making its trial data available through the joint industry Web portal The data cover trials of new medicines and new uses of current medications approved by regulatory agencies in the U.S. and Europe on or after 1 January 2014.

The company says a panel of scientists will review applications for access to data from clinical trials, down to the level of individual participants, after removing participants’ identifying information. Qualified researchers can also access clinical study reports and protocols.

Summaries of Bayer clinical trials are already available from the company’s Trial Finder Web page. The summaries can be searched by product, country, condition, trial status (from not yet recruiting through completed or suspended), phases, and availability of results.

Boehringer Ingelheim, in Ingelheim, Germany also makes available its trial data through the portal, and as with Bayer HealthCare, requests will be screened by a scientific review panel, with identifying information on individual trial participants removed. The company currently makes available reports of trials and related documents through a request form on its Web site.

Boehringer Ingelheim says data on all trials, regardless of outcome will be provided, going back as far as 1998. Results of late-stage (phase 3) clinical trials will also be submitted for publication in peer-reviewed journals within 18 months following completion of the study.

In July 2013, European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America agreed on a set of principles for clinical trial data transparency, with 1 January 2014 set as the target date for implementation. Several companies — GlaxoSmithKline, Roche, Sanofi, and Novartis — implemented similar trial data release plans, including the use of the Web portal.

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Hat tip: FirstWord Pharma

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