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Corporate Responsibility Report 2008

Q&As

Here we respond to questions raised by our stakeholders.

How are you assured that the risks for healthy volunteers who take experimental medicines for the first time are minimised?

Before a clinical trial can take place, a new compound must undergo a series of stringent laboratory tests. These tests involve the use of animals and human tissue to predict the effects of an investigational medicine in the human body, including any potential side effects. On the basis of the predictions we establish dosing levels with a sufficient margin of safety and/or appropriate monitoring procedures.

The ‘pre-clinical’ data from laboratory tests, and our proposal for the design of each ‘first time in human’ clinical trial, are reviewed by a GSK committee, known as the Global Safety Board, of experienced senior physicians and other experts who are independent of the project team. Regulatory authorities and independent ethics committees must approve the trial before it can go ahead.

Clinical trials are designed to minimise risk. For example, we initially give volunteers a very low dose of the investigational medicine and increase dosing gradually, carefully sequenced among subgroups, to be cautious in our approach. Trials of an investigational medicine being tested in humans for the first time are conducted in clinical units with rapid access to hospital emergency care.

All clinical trial volunteers are provided with information about the study, including potential risks, and have the opportunity to discuss these risks with researchers before deciding whether or not to participate. This is known as informed consent.

You plan to enter in to more research collaborations. How will you ensure that the organisations you partner with meet your research and animal welfare standards?

We recognise that working in collaboration with other organisations brings certain risks. We are developing routine safeguards to ensure our partners work according to the same core principles as GSK, including those that govern our use of animals in research. These checks will be applied when we are evaluating whether to enter into collaboration, and subsequently on an ongoing basis within the framework established to govern a collaboration, typically a Joint Steering Committee. GSK’s willingness to enter or continue a collaboration depends on having adequate assurance of a shared commitment to core principles.

GSK is opening an R&D facility in China. Will this affect your research standards? Is it a cost reduction exercise?

We have opened a new R&D facility in China which is focusing on R&D into neurodegenerative disorders, for which better therapies are desperately needed: Alzheimer’s disease, Parkinson’s disease and multiple sclerosis.

The costs of conducting research in China are currently relativity lower than those in other markets. However, lower costs are not the reason behind the decision to set up this new facility. The new centre enables us to benefit from accessing the vast talent pool and knowledge in life sciences in China, and to increase focus and depth in important disease areas.

Our R&D in China is conducted in accordance with GSK’s global quality and ethical standards. All R&D policies and monitoring procedures apply to our operations in China. We have committed significant regional and local resource to ensuring our operations in China comply with both Chinese government requirements and GSK’s global standards.