Steven Eaton, a former employee of Aptuit was found guilty at Edinburgh Sheriff’s Court in March
following a prosecution under the Good Laboratory Practice Regulations
1999, was today sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials. - The first time the Medicines and Healthcare Products Regulatory
Agency (MHRA) has successfully used these regulations to bring a
prosecution.
The case came about when Aptuit informed the MHRA that they had
identified serious irregularities in pre-clinical data generated to
support human clinical trials and the registration of new medicines.
The irregularities involved changing or providing false analytical
data that would be used to determine the concentration of medicine that
could be given to clinical trial subjects used to assess the safety and
efficacy of a new medicine.
The MHRA launched an investigation to identify the number of studies
affected and the impact the data irregularities would have on the
interpretation of important safety data. The investigation concluded
that Mr Eaton had selectively reported analytical data over a number of
years, dating back to 2003. During this period he selectively reported
data which was used to assess whether analytical methods were working
properly or to assess the concentration of the drug in blood. The data
manipulation ensured an experiment was deemed successful when in fact it
had failed.
The actions led to the review of many hundreds of safety studies
assessing the impact of the data manipulation and to ensure that the
compromised data was not used in future submissions to relevant
authorities without their knowledge.
The development of a number of new
medicines were significantly delayed and considerable cost to the study
sponsors was incurred as a result of the delay due to the fraudulent activities of Eaton.
Following a full assessment by the MHRA’s inspection team and
assessors it was concluded that the data integrity issues did not
invalidate the results of the clinical trials that were affected.
