The cases of companies D and F

Two medical directors of major international companies were discussing, over a gin and tonic, the cost of clinical pharmacology in contract research establishments in the UK. As is often the case, both were talking from recent examples and the conversation progressed to discussion of the design of the studies.

It became obvious to the two directors that they were talking about almost identical studies, being carried out at the same contract house, with similar agents. Both of these were cardiovascular agents potentially useful in treating hypertension.

As the evening wore on, it became obvious not only that they were talking about a similar study design with similar agents but that the results that they had obtained in their studies were similar if not identical.The two directors agreed, far into the night, to exchange final reports; they were not suspicious that any of the data had been fraudulently generated at this time.

At a subsequent meeting they compared notes because, when the reports were read, it was impossible to detect the difference between them other than that the name of the molecule had been changed. Even the shapes of the kinetic curves were identical and the calculated clearances and half lives were very similar.

To this date neither of the medical directors knows whether the data had been fraudulently generated. Needless to say both reports were abandoned, at substantial cost, both in terms of money paid to the centre and of delay in getting product licence approval.

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