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Feature Drug Development

A failed attempt at collaboration

BMJ 2013; 347 doi: (Published 04 September 2013) Cite this as: BMJ 2013;347:f5354
  1. Silvio Garattini, director,
  2. Vittorio Bertele´, head, laboratory of drug regulatory policies,
  3. Guido Bertolini, head, laboratory of clinical epidemiology
  1. 1IRCCS-Mario Negri Institute for Pharmacological Research, Milan, Italy
  1. Correspondence to: S Garattini silvio.garattini{at}

The Mario Negri Institute for Pharmacological Research, a non-profit independent foundation, has withheld its involvement in an Innovative Medicines Initiative project that included clinical research and development of a product owned by GlaxoSmithKline.

Although we fully support the idea of further collaboration with industry, on this occasion the cooperation was not quite what we had hoped for. GSK set down the protocol for the clinical research in the partnership, and when we questioned some of the company’s methodological choices—such as the comparator drug and sample size—it became clear that these were not open for discussion. A project agreement written by GSK and attached to the study protocol set out dozens of pages of rules and conditions that would effectively have made this a …

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