The trial materials

The clinical practice requires that all unused trial materials be accounted for on completion of a clinical study.

Of all the aspects that clinical trial monitors and clinical research associates find most fascinating, the one that captures the imagination is the review or audit of returned clinical trial materials. Quite often the first hint of trouble occurs after the review of returned trial materials.

It pays to be suspicious - bearing in mind that trial materials normally have been in a patient's home, handbag, pocket, or kitchen cabinet - if they seem to be too clean, too exact, or too similar. From my experience, trial materials that are actually taken as prescribed are very suspicious indeed. Although it is generally accepted that compliance in clinical trials is higher than compliance in routine medical practice, materials taken exactly as dispensed should be viewed with a great deal of scepticism.

The widespread introduction of calendar packing and blister packing has also provided a fruitful area for investigation. Calendar packs which start on the same day are obviously worthy of investigation. It is sometimes particularly illuminating to check the day of the week that it seems the medication was started on against the start date as entered on the case record form.

One of the mainstays of the detection of fraud is the recognition that a person's habitual behaviour will be reflected in the case record forms or other activities associated with the study.The use of blister packaging has led to some interesting examples. In one particular study of an antidepressant, it seems that the medication was being taken properly but examination of returned blister packages from several different "patients" showed that they had all started their medication from the same physical location on the blister strip. Obviously this is very unlikely to occur in real practice.

Two more case studies will further illustrate possible approaches in reviewing returned trial materials.

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