The case of trial P the unusual consequences of monitoring visits by clinical research associates

A large multicentre study of an injectable anti-infective agent for the management of intra-abdominal sepsis was being carried out by a European-based company. Monitoring visits by the clinical research associate were, after the initiation and set-up visits, to be held at monthly intervals.

One particular centre caught the attention of the data administrator, who plotted out the recruitment rate for the suspicious centre and all other centres.

This showed that at the end of month two, after the clinical research associates had been on a motivational campaign, recruitment picked up from five per month to just about six per month for most centres and then returned down to the baseline recruitment rate of five per month until the visit at the end of month five. At this point the clinical research associates told the investigators that recruitment was closing in one month with the inevitable upswing in recruitment rate.

With the suspect centre the upswing in recruitment after the visit at the end of month two was a little above average but not suspicious. What was suspicious was the very dramatic (in fact in this case doubling) increase of recruitment of patients when the investigator was informed that the study would close for recruitment in one or two months' time and no further patients would qualify for payment. Further investigation revealed that at least four of the patients recruited after the visit at the end of month four were not included in the study.

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