Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Man Jailed in Pre-Clinical Trial Data Scam Case

Published: Friday, April 19, 2013
Last Updated: Thursday, April 18, 2013
Bookmark and Share
The man was sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials.

Steven Eaton was found guilty at Edinburgh Sheriff’s Court in March following a prosecution under the Good Laboratory Practice Regulations 1999 - 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.

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. The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More Than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

UK Moves Towards Safe and Effective Electronic Cigarettes and Other NCPs
All nicotine-containing products, such as electronic cigarettes, are to be regulated as medicines in a move to make these products safer and more effective to reduce the harms of smoking.
Friday, July 12, 2013
MHRA Appoints New Chief Executive
The Medicines and Healthcare Products Regulatory Agency (MHRA) announced the appointment of Dr Ian Hudson as its Chief Executive.
Friday, July 05, 2013
Warning Over Potentially Toxic Chinese Herbal Medicine
MHRA warn people not to use Zheng Tian Wan to treat migraines.
Thursday, April 18, 2013
MHRA Prioritises Science and Research Support as Part of New Corporate Plan
MHRA announced its aim to be a leading regulator on the world stage in supporting science and research as part of its new five-year corporate plan.
Monday, April 15, 2013
Side Effects to be Discovered more Quickly, Leading to Safer Prescribing
BMJ Learning has teamed up with the MHRA to launch a new, interactive and multimedia learning module on pharmacovigilance.
Monday, April 15, 2013
The Medicines Act Hits 40
The 25th October 2008 will mark the 40th birthday of the Medicines Act. For the past 40 years, the Act has served as the corner-stone of domestic medicines regulation, safe guarding public health.
Friday, October 24, 2008
New Web Resource About Medicines
From today, people can access a new authoritative source of information on the Internet about medicines.
Friday, September 26, 2008
British Pharmacopoeia Launches New Website
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched the new British Pharmacopoeia (BP) website www.pharmacopoeia.gov.uk.
Tuesday, September 09, 2008
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
Researchers Find a Gap in the Brain’s Firewall Against Parkinson’s Disease
Researchers at NIH have found mouse study that identified a key player in the progression of the disorder.
Fat Cells That Amplify Nerve Signals in Response to Cold Also Affect Blood Sugar Metabolism
Researchers at UTSW have found that the protein connexin 43 forms cell-to-cell communication channels on the surface of emerging beige fat cells that amplify the signals from those few nerve fibers.
Drug to Treat Alcohol Use Disorder Shows Promise Among Drinkers With High Stress
The findings suggest that potential future studies with drugs targeting vasopressin blockade should focus on populations of people with AUD who also report high levels of stress.
C Dots Show Powerful Tumor Killing Effect
Nanoparticles known as Cornell dots, or C dots, have shown great promise as a therapeutic tool in the detection and treatment of cancer.
Faecal Bacteria Linked to Body Fat
Researchers at King’s College London have found a new link between the diversity of bacteria in human poo – known as the human faecal microbiome - and levels of abdominal body fat.
How Baby’s Genes Influence Birth Weight And Later Life Disease
The large-scale study could help to target new ways of preventing and treating these diseases.
Genes Underlying Dogs’ Social Ability Revealed
The social ability of dogs is affected by genes that also seem to influence human behaviour, according to a new study from Linköping University in Sweden.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!