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Feature Contract Research Organisations

Truly independent research?

BMJ 2008; 337 doi: (Published 21 August 2008) Cite this as: BMJ 2008;337:a1332
  1. Jeanne Lenzer, medical investigative journalist
  1. 1New York
  1. jeanne.lenzer{at}

    Research contracted to commercial or academic organisations might sound less biased than that done by industry. But as Jeanne Lenzer reports, influence is hard to avoid

    Drug and medical device companies are increasingly outsourcing clinical trials to commercial and academic contract research organisations (CROs). As well as cutting costs, this could potentially put desperately needed distance between sponsor and research product. If achieved, such distancing couldn’t come at a better time: a Harris Interactive poll shows that of the top 11 industry sectors, only tobacco companies had higher negative public opinion ratings than drug companies (76% and 52% respectively).1

    Although the literature about the biasing effects of industry sponsorship on medical research is rapidly expanding, little is known about whether studies conducted by CROs are subject to similar biases. This raises the question whether research outsourced to CROs is genuinely independent or subject to influence from corporate sponsors.

    Contracted research

    CROs contract with industry or public agencies to perform research activities such as recruiting participants, data collection, study design and analysis, and ghost writing. They reduce costs through economies of scale and by outsourcing to poorer nations.2 3 4 Kevin Schulman, associate director of the academic CRO Duke Clinical Research Institute, says that research conducted by CROs is independent, partly because they are not beholden to any one client. Only by providing high quality research, can they survive in the marketplace and retain credibility. Dr Schulman says his organisation’s strategy “is to have a mix of private and public sources of funding, and it’s more important for us to maintain the integrity of the university than our relationship with any individual sponsor.”

    However, CROs face a fundamental conflict of interest—if they do not please their commercial clients, they may be less likely to get more work from them. Instances of …

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