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Behind closed doors

Nature Biotechnology volume 32, pages 528–535 (2014)Cite this article

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Confidential business information is commonly used to hide data about industry products from public view. Researchers, regulators and companies are currently struggling to redefine who needs to know what about commercial products and when they need to know it.

Recent years have witnessed a growing chorus of criticism about data disclosure practices in the pharmaceutical industry. This has prompted parliamentary inquiries in the United Kingdom and spurred US and European government agencies to launch transparency initiatives on clinical data. Industry, too, is finally responding, with several European big pharma companies creating a system (http://www.clinicalstudydatarequest.com/) for releasing reports on human-testing data on approved drugs, at least to those individuals who qualify under their rules. Johnson & Johnson (New Brunswick, NJ, USA) has also declared its intention to release clinical trial data to an academic group, Yale's Open Data Access program (Box 1).

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Figure 1: Large swaths of regulatory documents—sometimes running into tens of pages—can be redacted by regulatory agencies if they feel the information can produce competitive harm.
Figure 2: CBI has increased over the last 20 years, whereas the number of field tests peaked in 2002 and declined.

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  1. Laura DeFrancesco is a Senior Editor at Nature Biotechnology ,

    Laura DeFrancesco

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DeFrancesco, L. Behind closed doors. Nat Biotechnol 32, 528–535 (2014). https://doi.org/10.1038/nbt.2923

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