The case of trial Z

Trial Z was a study with a topical application (gel formulation) of a non-steroidal anti-inflammatory drug carried out in the United Kingdom. It was a parallel group, multicentre, double blind placebo-controlled study using 20 centres, with 12 patients per centre.

At the first follow up visit to one particular centre, when the first two to three patients entered a review, the trial monitor voiced some concerns suggesting possible fraud. The monitor had noted that the returned trial materials all seemed to have been handled the same way. The tubes had been squeezed in an identical fashion. The monitor commented, "There are four people living in our house, we all squeeze our toothpaste differently - how is it that the three patients enrolled into the study at this centre seem to have squeezed their tubes identically - not only that, but the tubes seem to have been gripped in the middle and squeezed, very unlikely for a medication that was meant to have been given three to four times a day for five to seven days." At a subsequent visit the remaining tubes for the last nine patients from that centre all looked identical.

The returned samples for this centre were also unique in that their weights were a mean of 24 g± 6 g, whereas the tubes returned from the other centres showed a mean weight of 8g± 12 g. Examination of all the tubes returned from the suspect centre showed that they had all been gripped and squeezed in an identical manner - making it very unlikely that the materials had been used in the clinical trial by 12 different patients.

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