Clinical trial scam
April 18, 2013
A BRITISH man has been
sentenced to three months in
prison for altering pre-clinical trial
data, in a case brought by the UK
Medicines and Healthcare Products
Regulatory Agency (MHRA).
A company called Aptuit had
informed the MHRA about serious
irregularities in pre-clinical data
generated support human trials and
the registration of new medicines.
A subsequent investigation found
that Steve Eaton, an ex-employee of
the firm, had “selectively reported
analytical data over a number of
years, dating back to 2003”.
“The data manipulation ensured
an experiment was deemed
successful when in fact it had
failed,” the MHRA said.
Consequently many hundreds of
safety studies had to be reviewed
to assess the impact of the data
manipulation, and to ensure that
the compromised data was not
used in future submissions.
A number of new medicines were
significantly delayed as a result.
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