Parexel back in hot water over drug trial errors

Although clearing Parexel from contributing to the recent drug trial disaster, a final UK Medicines and Healthcare products Regulatory Agency (MHRA) report slammed the US firm for making a number of basic errors during the trial process.

As reported here, the MHRA has accused global contract research firm Parexel of breaking a number of safety rules during the trial by failing to follow correct procedures and of making errors over contracts and patient records.

According to the report, Parexel did not adhere to documentation procedures during the trial.

Alarmingly, there was also no contract in existence for the bank-screening physician at the time they were employed (although one was subsequently issued). Parexel's principal investigator failed to authorise in their log the full work remit for the bank-screening physician at the start of their employment, the investigation found.

At the time of the drama, the MHRA also found that Parexel was non-compliant with the unblinding procedure, meaning that the placebo volunteers were allowed to leave the trial before appropriate checks were taken to confirm that they were the two subjects that had received the placebo.

Surprisingly, prior to beginning the trial there was also no contract in place between TeGenero and Parexel, although again, one was subsequently issued, and there was only a draft contract in existence between Parexel and the private laboratory they had engaged.

In addition, Parexel had failed to review TeGenero's insurance policy to ensure that one was in place and that there were no exclusion categories within it that might impact upon their volunteers. There was also no formal system in place to provide 24-hour medical cover, the report stated.

The proper colloquial term for a mess like this is "it's a dog's breakfast"