Trial Y was a study of an oral non-steroidal anti-inflammatory drug. It was a prospective, double blind, placebo-controlled, crossover study carried out as part of a phase III programme. Escape analgesia (paracetamol) was provided. The consumption rates for the escape analgesia were calculated on a daily basis and were one of the parameters of efficacy.
The centre carrying out the study had a proven track record in similar work and seemed to have carried out previous studies quickly and efficiently.
The company statistician was the first to point out an anomaly. It was obvious from reviewing the data that, in those treatment periods when the patients should have been receiving the active drug, their analgesic consumption seemed to remain the same as when they were receiving placebo. As previous studies had shown efficacy this was very suspicious.
There were three explanations: there had been problems in clinical trial materials - not unknown - and the active drug was in fact missing from the treatment schedules (that is, the patients received placebo all the time); or, secondly, the drug was not active; or, thirdly, the patients were not taking the medication.
Analysis of retention samples, or surplus materials unallocated from the trial programme, and of returned samples from the study, confirmed that the active drug was present in the appropriate tablets. A review of the blister packaging of the trial materials suggested that the patients were in fact taking them as directed. A review of other clinical trial data suggested that the dose being given in this study was adequate to achieve an analgesic effect, which should have led to a reduction in the consumption of escape analgesia.
If the investigator, or company employee, has inserted clinically sensible values, taking into account an individual patient's previous and subsequent results, a fraud may be impossible to detect without source data verification.
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