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Press release: Pre-clinical trial data scam – first ever successful prosecution under Good Laboratory Practice Regulations

Press release

Date: 12 March 2013
Time: 13:00
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

A man was today found guilty at Edinburgh Sherriff’s Court for altering pre-clinical trial data designed to support applications to perform clinical trials. Mr Steven Eaton was prosecuted under the Good Laboratory Practice Regulations 1999 - the first time the MHRA has successfully used these regulations to bring a prosecution. Mr Eaton, a former employee of Aptuit, a large research organisation formerly based in Edinburgh, was told to return to court for sentencing on 17 April 2013.

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.

As a result of Mr Eaton’s actions 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.

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.

Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards said, “Mr Eaton’s actions directly impacted on the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression. This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.’

Notes to Editor

1. Link to Good Laboratory Practice regulations

2. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
Page last modified: 12 March 2013