Corporate Banner
Satellite Banner
Medicinal Chemistry
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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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

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
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
Tuesday, September 09, 2008
Scientific News
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
New Hope for Personalized Treatment of Eczema
Pharmaceutical researchers at Oregon State University have developed a new approach to treat eczema and other inflammatory skin disorders that would use individual tests and advanced science to create personalized treatments based on each person's lipid deficiencies.
Inroads Against Leukaemia
Potential for halting disease in molecule isolated from sea sponges.
Researchers Disguise Drugs As Platelets to Target Cancer
Researchers have for the first time developed a technique that coats anticancer drugs in membranes made from a patient’s own platelets.
HIV Patients Should Be Included in Early Clinical Trials of Anti-TB Drugs
Tuberculosis is the number one cause of death in HIV-infected patients in Africa and a leading cause of death in this population worldwide.
Combination Drug Therapy Shrinks Pancreatic Tumors In Mice
Two drugs that affect the structure and function of DNA have been found to block the growth of pancreatic tumor cells in mice, researchers hope the drugs can soon be tested in humans with the disease.
Seeking A Better Way To Design Drugs
NIH funds research at Worcester Polytechnic Institute to advance a new chemical process for more effective drug development and manufacturing.
Old Drug Performs New Tricks
Cambridge-led research reveals the powers of a "wonder drug" that has lain under the noses of doctors for 50 years.
Diabetes Drugs May Actually Release Sugar Into the Blood
A family of drugs used to treat Type 2 diabetes could promote the release of sugars into the blood - something the drugs are supposed to prevent, Cambridge scientists have claimed.
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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos