MHRA - Good Clinical Practice duped by GSK?

MHRA - Good Clinical Practice (GCP) Inspectorate is part of the Inspections & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation.

...or so it says

Why then did it fail regarding the Paxil 329 study?

Here is the EU Directive definition of 'Good Clinical practice' taken from the MHRA website

“Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”

Hmmm - really?

And what would those 'requirements' be then?

Next paragraph on the MHRA webpage tells us.

Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.

It seems the MHRA's 'Good Clinical Practice' has been duped by GlaxoSmithKline... or maybe just 'overlooked'?

Surely they have provisions that such an event couldn't happen?

Enter the MHRA Good Clinical Practice Inspectorate:

What is the MHRA GCP Inspectorate?

In the UK, the GCP inspectorate is responsible for inspecting clinical trials for compliance with Good Clinical Practice.

The GCP inspectorate consists of a team of GCP inspectors. By conducting inspections at the sites of organisations conducting or involved in clinical trials, the GCP Inspectors assess compliance with the requirements of legislation and guidelines relating to conduct of clinical trials involving investigational medicinal product. Each Inspector has a statutory duty to assess compliance with medicines legislation and holds a warrant accordingly.

I'll ask again... What about Paxil Study 329?

For further inforomation ask the MHRA*

*Be prepared - a thesaurus is always a good tool when reading responses from the MHRA - Be warned though because the meaning of a word in your thesaurus may differ from the one the MHRA uses. The word 'Transparent' for example.

Read more about Paxil Study 329 HERE

Watch a two and a half minute video about Paxil Study 329 HERE

Alternatively you could always read the MHRA's take on Good Clinical Practice HERE and if you have questions to ask them then please do not hesitate to contact them
here -> info@mhra.gsi.gov.uk

For more recent failings by the MHRA and their 'Good Clinical Practice' read about the TGN1412 drug trials HERE

Also click on the following links:

"Six seriously ill in London hospital as drug trial goes wrong." Breaitbart.com. March 15, 2006

TeGenero AG. Press Releases. March 15, 2006

"They say he needs a miracle." BBC News. March 15, 2006

"London Drug Trial Victims May Be Ill for Life, Lawyers Say." Bloomberg.com. April 21, 2006.

"Drug trial victim may lose fingers and toes." Reuters. April 18, 2006.