We Will Share All Trial Data, Says GSK

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We Will Share All Trial Data, Says GSK

Main Category: Pharma Industry / Biotech Industry
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Oct 2012

After being fined $3 billion in the USA for concealing safety issues, GSK (GlaxoSmithKline PLC) says that it will make its clinical trial data available to the scientific community in a new measure to further advance its commitment towards "greater openness, transparency and collaboration".

In July 2012, GSK pleaded guilty to promoting two drugs - antidepressants Paxil and Wellbutrin - for unapproved uses, as well as withholding safety data regarding diabetes drug, Avandia, from the FDA (Food and Drug Administration).

The $3 billion settlement was to cover criminal fines as well as civil settlements with state and federal governments. The case involved 10 medications, including Advair, Avandia, Wellbutrin, and Paxil

The company was also found guilty of bribing doctors.

GSK Chairman, Sir Andrew Witty, spoke at a meeting hosted by the Wellcome Trust in London yesterday. He said that the company will announce new steps to build on its "open innovation" approach to R&D.

Sir Andrew said:

"As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges. However, the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone. We need to take a different approach - one focused on partnership, collaboration and openness.

By being more open with our clinical trial data, we also hope to help further scientific understanding. I am pleased with the progress we have made so far to evolve our business model but we recognise there is more we can do and the new initiatives outlined today will enable us to build on this work."

Sir Mark Walport, Director of the Wellcome Trust, said "In its commitment towards more openness and collaboration, GSK is setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other. GSK's moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today."

GSK's TB 'compound library' opens up

Researchers at GSK have screened their databank of over two million compounds for any that might have potential for becoming drugs for treating TB (tuberculosis). The results of their search will be published in a scientific journal shortly.

The company says that so far, about 200 "promising hits" have been made.

GSK says this is a pharmaceutical industry first. Never before has a drugmaker made its list of proprietary compounds that have demonstrated potential against TB been made available to the public.

GSK says that it hopes this will encourage other companies and laboratories around the world to do the same against a disease that kills approximately 1.5 million people annually.

Total transparency in clinical trials

GSK says it is "fully committed to sharing information about our clinical trials". A summary of every clinical trial, including data when it commences as well as summary results will be posted online and will be accessible to all, regardless of whether it is positive or negative information.

The company says the website - The GlaxoSmithKline (GSK) Clinical Study Register - already includes the result summaries of nearly 4,500 clinical trials. At the moment, that website is receiving almost 10,000 visitors each month. Sir Andrew said GSK will also publish the results of all clinical trials that evaluate its medications, no matter what the findings are, to peer-reviewed academic journals.

Researchers will also be able to access detailed anonymised patient-level data from clinical trials of its approved medications and investigational drugs that were discontinued.

Written by Christian Nordqvist
Copyright: MediLexicon International Ltd

Original article posted on Medical News Today.
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