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The potential for bias in reporting of industry-sponsored clinical trials.

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      Abstract

      Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of money required for the discovery, development and commercialization of new medicines. As the ability of major, mid-size and small pharmaceutical companies to innovate has waned, as evidenced by the seemingly relentless decline in the numbers of new medicines approved by Food and Drug Administration and European Medicines Agency year-on-year, not only has the cost per new approved medicine risen: so too has the public and media concern about the extent to which the pharmaceutical industry is open and honest about the efficacy, safety and quality of the drugs we manufacture and sell. In 2005 an Editorial in Journal of the American Medical Association made clear that, so great was their concern about misleading reporting of industry-sponsored studies, henceforth no article would be published that was not also guaranteed by independent statistical analysis. We examine the precursors to this Editorial, as well as its immediate and lasting effects for statisticians, for the manner in which statistical analysis is carried out, and for the industry more generally.

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      Author and article information

      Affiliations
      [1 ] Pfizer Ltd, Clinical Research, Sandwich, Kent, UK. stephen.pyke@pfizer.com
      Journal
      Pharm Stat
      Pharmaceutical statistics
      1539-1612
      1539-1604
      : 10
      : 1
      21275037
      10.1002/pst.429
      Copyright © 2010 John Wiley & Sons, Ltd.

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