Edinburgh Sheriff’s Court in the UK has sentenced a former employee of drug discovery and development firm Aptuit to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials.
The court found Steven Eaton guilty subsequent to prosecution under the Good Laboratory Practice Regulations 1999.
It is the first time that The Medicines and Healthcare Products Regulatory Agency (MHRA) successfully used the regulations to bring a prosecution.
MHRA Inspection, Enforcement and Standards director Gerald Heddell said Mr. Eaton’s actions directly impacted on the validity of clinical trials and delayed market arrival of a number of medicines, including a depression drug.
"The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health," Heddell added.
Earlier Aptuit indentified and informed the MHRA about irregularities in pre-clinical data generated to support human clinical trials and the registration of new medicines.
The irregularities include changing or providing false analytical data, which could form a base to fix the concentration of medicine administered to the study subjects to determine the safety and efficacy of new medicine.
MHRA investigation found that since 2003, Eaton selectively reported analytical data used to assess the working of analytical methods to assess the concentration of the drug in blood.
The data manipulation showed an experiment to be successful when it had actually failed.
Eaton’s actions led to the delay of the development of a number of new medicines and incurrence of considerable cost to the study sponsors.
The inspection team concluded that the data integrity issues did not nullify the results of the clinical trials that were affected.