Applied Clinical Trials
A serious warning was issued this week to any clinical researchers who were under the impression that their reputations and livelihoods would remain largely unaffected if they manipulated or fabricated data.
On Wednesday, Steven Eaton, from Cambridgeshire in the U.K., was sentenced to three months in prison for altering preclinical data designed to support applications to perform clinical trials, as we reported yesterday. Eaton was found guilty at Edinburgh Sheriff’s Court in March, following a prosecution under the Good Laboratory Practice Regulations 1999.
“We depend on research to be as truthful as it can be. If someone has been proved to have deliberately falsifed it, that is fraud, and people’s lives might have been affected,” Jean Turner, M.D., executive director of the Scotland Patients Association, told The Scotsman newspaper. “Once trust has gone, it’s really very difficult to restore. See what happened with the MMR (measles, mumps, and rubella vaccine) - a lot of people lost faith [because of discredited research] and we now have a measles outbreak in Wales.”
Significantly, this is the first time the Medicines and Healthcare Products Regulatory Agency (MHRA) has successfully used these regulations to bring a prosecution.
Defense solicitor advocate Jim Stephenson told a BBC News reporter that his client had given up working as a scientist. “He is unlikely to ever undertake this type of work ever again,” Stephenson commented.
According to Sheriff Michael O'Grady, "I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly - you could have caused cancer patients unquestionable harm,” he is quoted in the BBC News report. "Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable."
The case came about when representatives from Aptuit informed the MHRA that they had identified serious irregularities in pre-clinical data. They realized that something was amiss, and contacted the authorities in February 2009. Investigators from the MHRA discovered that Eaton had been selectively reporting research data since 2003. Eaton changed analytical data that would be used to determine the concentration of medicine that could be given to clinical trial subjects. The data manipulation ensured an experiment was deemed successful when in fact it had failed.
For further details on the case, click here.