• Home
• Responsibility
• CR Review 2007
• Research practices

Research practices

How do you make patient safety a priority?

All medicines have potential risks as well as benefits, although not everyone who takes a medicine will experience side effects. It is important that we identify, evaluate and minimise safety concerns to ensure that the overall benefits of a medicine outweigh any risks.

What we are doing

We aim to make our medicines as safe as possible by evaluating the risks and benefits at every stage from initial research, through to clinical trials and then after a new product is approved for sale. In addition the safety of volunteers who participate in our research is of paramount importance. Open communication of the results of our research which provide information on the efficacy and safety of our medicines is also extremely important.

Our Clinical Trial Register
Our Clinical Trial Register was launched in 2004 and is designed to supplement prescribing information and the publication of trial results in the scientific literature. Anyone with access to the internet can view our Register at ctr.gsk.co.uk.

At the end of 2007 there were 3,089 clinical trial summaries on our Register. This includes clinical trials of our major marketed products which have been completed since the formation of GSK in 2000, or that were completed before this and are likely to inform medical judgement.

Our objective is to disclose on our Register the trial result summaries for all new products within 12 months of the product reaching the market. We also aim to disclose the results of trials completed after a product is approved for marketing within one year of trial completion. We met this objective in 2007.

We are re-designing our Clinical Trial Register to improve its usability and make it easier for users to retrieve information. This will include improving the links between the protocol and results for each trial enabling users to directly compare the two, and extending the search function to enable users to search by disease area or for trials relating to a particular medicine.

Working with others
We are working with governments, industry partners and policy-makers in efforts to build an enhanced safety system.

For example GSK is a key partner with the US Food and Drug Administration (FDA), other pharmaceutical companies and academia in the US to explore the development of a new system for the detection of adverse events and benefits of medicines using large healthcare system databases.

In addition, in 2007 we joined with other pharmaceutical companies, academic institutions and the FDA to launch a new patient safety collaboration – the Serious Adverse Events Consortium.

The Consortium aims to improve patient safety through genetic research. Its work will include researching genetic markers that may help predict who is at risk for serious side effects, and using genetic research to identify which patients will benefit most from which medicines.

Q. Why doesn’t GSK publish the results of trials that don’t result in marketed medicines – couldn’t these help to advance scientific understanding?

A. This is an evolving area and this year we reviewed our policy. Our Clinical Trial Register, which we publish on the internet, includes results summaries of GSK-sponsored trials that do not result in marketed medicines, in the following circumstances:

• GSK-sponsored Phase III clinical trials of investigational medicines that are no longer being developed for any indication by GSK or any third party
• GSK-sponsored Phase II clinical trials of investigational medicines when the research programme has been terminated due to a safety issue associated with the mechanism of action.

Back to top