Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

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
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 2,800+ scientific posters on ePosters
  • More than 4,000+ 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 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

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
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
Scientific News
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Scroll Up
Scroll Down

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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos